Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200
Reported: November 8, 2023 Initiated: September 12, 2023 #Z-0195-2024
Product Description
Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200
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
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 237 units
- Distribution
- Nationwide
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 237 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 8, 2023. Severity: Moderate. Recall number: Z-0195-2024.
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