Artis Zee Ceiling
Catalogue number 10094137, listed by Siemens Healthcare Limited, Canada, under System, X-Ray, Tomography, Computed. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
1catalogue number
14510(k) clearances naming this product code
Who Else Makes It
Concentrated in Beijing (2), Shanghai (2), Jiangsu (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Qisda Electronics (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Neusoft Medical Systems Co., Ltd. | Shenyang | Liaoning | Manufacturer | 1 |
| Philips Health Technology (China) Co., Ltd. Shenyang Branch | Shenyang | Liaoning | Specification developer | 1 |
Record
| Listed by | Siemens Healthcare Limited, Canada |
|---|---|
| FDA product code | JAK |
| Device type | System, X-Ray, Tomography, Computed |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K122644 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-17 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment humidity 10 to 95 % RH; Handling environment humidity 20 to 75 % RH; Handling environment temperature 15 to 30 °C; Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -20 to 70 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10094137 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Visicoil | IZI Medical Products LLC | 48 |
| Visicoil MR | IZI Medical Products LLC | 41 |
| Illumisite | Covidien LP | 25 |
| Imbio LDA | Imbio, LLC | 24 |
| Edge | Covidien LP | 20 |
| Revolution | GE Hangwei Medical Systems Co., Ltd. | 20 |
| Gold Fiducial | IZI Medical Products LLC | 20 |
| superDimension | Covidien LP | 17 |
| Lodox | Lodox Systems (PTY) Ltd. | 12 |
| Revolution | GE Medical Systems, L.L.C. | 12 |
| Toshiba Scanner | Canon Inc. | 10 |
| syngo.CT Dual Energy | Siemens Healthcare Limited | 7 |
Showing 12 of 495. All products under System, X-Ray, Tomography, Computed
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233753 | 2024-03-21 |
| K213713 | 2022-08-11 |
| K170221 | 2017-04-21 |
| K110366 | 2011-04-12 |
| K071310 | 2007-06-08 |
| K063507 | 2006-11-30 |
| K053024 | 2005-11-04 |
| K050867 | 2005-04-14 |
| K991600 | 1999-06-09 |
| K984634 | 1999-03-12 |
| K982536 | 1998-11-24 |
| K941546 | 1994-09-20 |
| K790975 | 1979-07-30 |
| K790342 | 1979-03-22 |
Recalls Naming This Product
71 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2024-03-21 | Class II | Device Design | Coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message TUBE HOT, have a break. the system cannot be | 583 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-12-16 | Class II | Software design | In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach full operating mode. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternati | 609 US; 1627 worldwide | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-08-10 | Class II | Device Design | Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to rele | 1,389 (590 US; 799 OUS) (Total) | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-05-24 | Class II | Component design/selection | It may occur that after system startup no stand movement is possible any longer in the event of a discharged BIOS battery of the robotic stand control PC. If this problem occurs during startup, all stand movements are blocked and can only b | 233 worldwide; 32 US | 2025-01-22 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-02-23 | Class II | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message “TUBE HOT, have a break”. Several minut | 305 systems | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-02-23 | Class II | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message “TUBE HOT, have a break”. Several minut | 709 systems | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-02-23 | Class II | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message “TUBE HOT, have a break”. Several minut | 277 systems | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-02-23 | Class II | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message “TUBE HOT, have a break”. Several minut | 373 systems | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-02-23 | Class II | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message “TUBE HOT, have a break”. Several minut | 24 systems | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-02-23 | Class II | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message “TUBE HOT, have a break”. Several minut | 7 systems | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-02-23 | Class II | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message “TUBE HOT, have a break”. Several minut | 183 systems | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-02-23 | Class II | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message “TUBE HOT, have a break”. Several minut | 80 systems | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-02-23 | Class II | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message “TUBE HOT, have a break”. Several minut | 418 systems | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-02-23 | Class II | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message “TUBE HOT, have a break”. Several minut | 269 systems | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-02-23 | Class II | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message “TUBE HOT, have a break”. Several minut | 38 systems | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-02-23 | Class II | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message “TUBE HOT, have a break”. Several minut | 33 systems | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-02-23 | Class II | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message “TUBE HOT, have a break”. Several minut | 81 systems | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-02-23 | Class II | Device Design | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message “TUBE HOT, have a break”. Several minut | 69 systems | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-10-20 | Class II | Software design | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure | 3 units | 2024-06-18 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-10-20 | Class II | Software design | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure | 8 units | 2024-06-18 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-10-20 | Class II | Software design | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure | 19 units | 2024-06-18 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-10-20 | Class II | Software design | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure | 2 units | 2024-06-18 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-10-20 | Class II | Software design | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure | 8 units | 2024-06-18 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-10-20 | Class II | Software design | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure | 67 units | 2024-06-18 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-10-20 | Class II | Software design | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure | 15 units | 2024-06-18 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-10-20 | Class II | Software design | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure | 3 units | 2024-06-18 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-10-20 | Class II | Software design | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure | 15 units | 2024-06-18 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-10-20 | Class II | Software design | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure | 2 units | 2024-06-18 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-09-24 | Class II | Software design | Software error, the software can produce an incorrect interpretation of the table rotation if the table has been rotated by more than 4degrees in either direction. This can cause the 3D image reconstruction to be shown rotated by up to 5 de | 43 US | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-06-30 | Class II | Software design | Due to a software error, the IAS (Image Acquisition System) may sporadically fail during startup/ restart, and result in delay of clinical treatment | 70 US (172 WW) | 2023-02-10 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-03-30 | Class II | Equipment maintenance | Due to inappropriate cleaning, some Artis systems show unexpected corrosion of visible belts which are needed to move system parts (e.g. C-Arm), Increased corrosion may lead to a malfunction of the belts which may result in limited function | 3,320 units U.S. | 2022-07-12 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-03-26 | Class II | Device Design | Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of the inner C-arm, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where it | 772 units U.S. | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2020-11-30 | Class II | Software design | When the user changes frame rates from lower frequency (e.g. 10 f/s) to higher frequency (e.g. 30 f/s) during continuous release of Fluoro “Fluoro Override”, the measured Air Kerma Rate can exceed the regulatory limits. | 5602 | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2020-10-21 | Class II | Employee error | Some electronic components within the generator were equipped with an incorrect protection diode. As a result, protection against overvoltage may be inadequate, and the system may not function properly in the event an overvoltage situation | 26 distributed worldwide (4 in US) | 2021-05-05 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2020-08-03 | Class II | Software Manufacturing/Software Deployment | Potential exists for the collision supervision not to work properly following loss of the individual room configuration data settings causing danger of collision with fix mounted room equipment, walls or floor may occur. This might cause co | 124 U.S | 2021-02-03 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2020-04-30 | Class II | Nonconforming Material/Component | Artis systems containing a Multi Display Manager of a specific lot, the power distributor may lead to an increased electrical contact resistance or the interruption of electrical contact, and result in planned procedures to be terminated an | 15 US | 2020-09-11 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2020-02-14 | Class II | Software design | A software issue could potentially cause the stand and table movements to be blocked. | 1452 worldwide (638 US) | 2021-04-20 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2020-02-14 | Class II | Software design | A software issue could potentially cause the stand and table movements to be blocked. | 1452 worldwide (638 US) | 2021-04-20 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2020-02-14 | Class II | Software design | A software issue could potentially cause the stand and table movements to be blocked. | 1452 worldwide (638 US) | 2021-04-20 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2019-11-14 | Class II | Software design | In affected Artis zee floor Interventional Fluoroscopic X-Ray Systems, the activation of a collision sensor will cause a block the movement of the floating tabletop and could result in a delay or interruption of a procedure. | 3 | 2020-05-12 |
Showing 40 of 71.
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.