Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502
FDA device recall Z-1243-2022 · posted 2022-06-06 · Open, Classified
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- 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 continued on an alternate system.
- Action taken
- On April 13, 2022, the firm notified customers via an Urgent Medical Device Correction letter. Customers were informed of the software issues. the software in the affected systems will be updated to correct the issue. Siemens' service organization will contact customers to arrange a date to perform the corrective action. Please feel free to contact Siemens' service organization for an earlier appointment at 1-800-888-7436.
- Root cause
- Software Design Change
- Status
- Open, Classified
- Product code
- DQK
- Quantity affected
- 443
- Distribution
- Domestic distribution nationwide.
- Date initiated
- 2022-04-13
- Date posted
- 2022-06-06
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Sensis (K150493) | Siemens Medi Cal Solutions, Inc. | 2015-06-30 |