***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment
FDA device recall Z-0196-2024 · posted 2023-10-27 · Open, Classified
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure
- Action taken
- Siemens Medical Solutions USA issued Urgent Medical Device Correction Letter (AX035/23/S).Letter states reason for recall, health risk and action to take. Siemens will correct the software error via Update Instruction AX036/23/S. With software version VA30K, the user interface of Cios VA30 systems will be changed to consider the current standards DIN 6862-3 and IEC 60601-2-54. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Customer Safety Advisory Notice. Please respond within 14 days of receiving this notification. If you have received this notification by email via Adobe GigaSign, kindly sign with your digital signature to acknowledge that you have read and understand the content provided. If you have received this customer notification by delivery by the US Postal Service or by FedEx, please send an email to recallsandrefusals.team@siemens-healthineers.com acknowledging that you have read and understand the content provided. Please ensure that all users of the affected products within your organization and others who may need to be informed will receive the relevant safety information provided within this notice and will comply with the recommendations therein.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- ***Updated 12/4/23*** 186 units Cios Flow, 181 units Cios Spin
- Distribution
- Nationwide
- Date initiated
- 2023-09-12
- Date posted
- 2023-10-27
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Cios Spin (K210054) | Siemens Medical Systems USA, Inc. | 2021-02-05 |
| Cios Flow (K203504) | Siemens Medical Solutions USA, Inc. | 2020-12-22 |