Sensis
Catalogue number 10764561, listed by Siemens Healthcare Limited, Canada, under Computer, Diagnostic, Programmable. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (7), Shanghai (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Dongguan Ergotron Precision Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd | Shenzhen | Guangdong | Manufacturer | 7 |
| Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC | Shanghai | Shanghai | Specification developer | 6 |
| Shenzhen Carewell Electronics Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Siemens Healthcare Limited, Canada |
|---|---|
| FDA product code | DQK |
| Device type | Computer, Diagnostic, Programmable |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1425 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K131812 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Storage | Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 10 to 95 % RH; Handling environment humidity 20 to 75 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment temperature 10 to 35 °C; Storage environment temperature -20 to 70 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10764561 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EnSite™ | St. Jude Medical | 177 |
| Computer, Diagnostic, Programmable | St. Jude Medical | 57 |
| MediGuide™ | St. Jude Medical | 41 |
| AcQMap | Acutus Medical, Inc. | 38 |
| WorkMate Claris™ | St. Jude Medical | 35 |
| iLab Ultrasound Imaging System | Boston Scientific Corporation | 32 |
| Rhythmia™ Mapping System | Boston Scientific Corporation | 31 |
| Sentinel | Spacelabs Healthcare (Washington), Inc | 28 |
| Rhythmia HDx™ | Boston Scientific Corporation | 26 |
| EnSite Precision™ | St. Jude Medical | 23 |
| PathfinderSL | Spacelabs Healthcare (Washington), Inc | 22 |
| Labsystem™ PRO | Boston Scientific Corporation | 19 |
Showing 12 of 228. All products under Computer, Diagnostic, Programmable
Recalls Naming This Product
10 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 | 2022-11-16 | Class II | Software design | The firm will be performing a software update to address a software error which affects the listed products. This correction addresses four potential software issues: 1) “PASSWORD STORE CORRUPTED” error message during system boot; 2) Su | 2213 distributed worldwide; 638 US | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-07-12 | Class III | Device Design | The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the possibility of mounting the Signal Input Box on an accessory rail (e.g., at the patient table), In the event the mounting position deviates fr | 399 units U.S. | 2024-11-07 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-06-15 | Class II | Device Design | Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a longer period of inactivity to the Sensis Vibe system resulting in no vital signs bein | 2 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-06-15 | Class II | Device Design | Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a longer period of inactivity to the Sensis Vibe system resulting in no vital signs bein | 13 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2022-04-13 | Class II | Software Design Change | Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be conti | 443 | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-11-23 | Class II | Software design | Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD12A, which could cause possible hazard to patients, operators, or other persons and equipment. Under certain sporadic circumstances, | 1047 | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-03-04 | Class II | Software design | Due to the configuration of certain Windows Service Permissions within the operating systems of the Sensis/ Sensis Vibe computer, there is a risk for exposure of sensitive information, manipulation of data, or Denial of Service attacks | 99 units | 2024-09-30 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2021-01-27 | Class II | Software design | System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system | 37 US | 2021-10-25 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2020-07-24 | Class II | Process design | The connector linking the EtCO2 module to the HemoBox may break and become damaged, if the connector is re-attached to the HemoBox in this damaged state, under certain incorrect pin alignment conditions, the HemoBox may stop functioning and | 110 units US | 2021-11-02 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2018-11-29 | Class II | Software design | A software error may result in a system crash. The system must be restarted before the clinical procedure can be continued. The ablation treatment must be performed with a different system or without the use of the interface. | 1 | 2020-05-07 |
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.