Villa Sistemi Medicali
2 catalogue numbers from Apollo EZ, listed by Villa Sistemi Medicali SPA, under Table, Radiologic. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Beijing (1), Shanghai (1), Tianjin (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
| GE Healthcare (Tianjin) Company Limited | Tianjin | Tianjin | Specification developer | 5 |
| Baxter Medical Systems (Suzhou) Co., Ltd. | Taicang | Jiangsu | Contract manufacturer | 4 |
Record
| Listed by | Villa Sistemi Medicali SPA |
|---|---|
| FDA product code | KXJ |
| Device type | Table, Radiologic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1980 |
| 510(k) | K050190 |
| Record published | 2016-09-24 |
| Record revised | 2019-03-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Apollo EZ | In distribution | |
| Apollo DRF | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tidi | Tidi Products, LLC | 1,329 |
| Table, Radiologic | Domico Med-Device, LLC | 351 |
| Hillrom™ | Baxter Medical Systems GmbH + Co. KG | 167 |
| Trumpf Medical | Baxter Medical Systems GmbH + Co. KG | 118 |
| Scancoat | Domico Med-Device, LLC | 82 |
| Gems | Tidi Products, LLC | 71 |
| Pads | Baxter Medical Systems GmbH + Co. KG | 41 |
| Bone Foam | Tidi Products, LLC | 25 |
| TS 7500 | Baxter Medical Systems GmbH + Co. KG | 21 |
| Orthopedic Extension | Baxter Medical Systems GmbH + Co. KG | 19 |
| Bionix | Tidi Products, LLC | 16 |
| Control Units | Baxter Medical Systems GmbH + Co. KG | 11 |
Showing 12 of 107. All products under Table, Radiologic
Recalls Naming This Product
14 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 |
|---|---|---|---|---|---|---|---|
| Villa Sistemi Medicali S.P.A. | 510(k) number | 2019-11-04 | Class II | Device Design | An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditi | 46 | |
| Villa Sistemi Medicali S.P.A. | 510(k) number | 2019-11-04 | Class II | Device Design | An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditi | 3 | |
| Villa Sistemi Medicali S.P.A. | 510(k) number | 2019-11-04 | Class II | Device Design | An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditi | 7 | |
| Villa Sistemi Medicali S.P.A. | 510(k) number | 2019-11-04 | Class II | Device Design | An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditi | 1 | |
| Villa Sistemi Medicali S.P.A. | 510(k) number | 2016-12-27 | Class II | Nonconforming Material/Component | Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position. | 65 devices in total | 2021-03-09 |
| Villa Sistemi Medicali S.P.A. | 510(k) number | 2016-12-27 | Class II | Nonconforming Material/Component | Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position. | 65 devices in total | 2021-03-09 |
| Villa Sistemi Medicali S.P.A. | 510(k) number | 2016-12-27 | Class II | Nonconforming Material/Component | Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position. | 65 devices in total | 2021-03-09 |
| Villa Sistemi Medicali S.P.A. | 510(k) number | 2016-12-27 | Class II | Nonconforming Material/Component | Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position. | 65 devices in total | 2021-03-09 |
| Acteon, Inc. | 510(k) number | 2016-02-19 | Class II | Device Design | The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) T | 66 distributed in US | |
| Acteon, Inc. | 510(k) number | 2016-02-19 | Class II | Device Design | The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) T | 66 distributed in US | |
| Acteon, Inc. | 510(k) number | 2016-02-19 | Class II | Device Design | The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) T | 66 distributed in US | |
| Acteon, Inc. | 510(k) number | 2016-02-19 | Class II | Device Design | The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) T | 66 distributed in US | |
| Acteon, Inc. | 510(k) number | 2014-12-14 | Class II | Radiation Control for Health and Safety Act | The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality | 30 units distributed in the US | 2017-03-16 |
| Acteon, Inc. | 510(k) number | 2013-08-02 | Class II | Radiation Control for Health and Safety Act | It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30×30 (12″x12″) and 15×15 (6″x6). This could result in a deviation of the displayed values of Air Kerma Rate and Cumulated Air Kerma from | 22 units within US | 2016-07-25 |
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.