Recalls / —
—#174336
Product
Cios care fusion system
- FDA product code
- OWB — Interventional Fluoroscopic X-Ray System
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K153244
- Affected lot / code info
- material # 10308192 Serial # 31375
Why it was recalled
DAP chamber may be missing an insulating foil
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
1. Siemens will inspect the DAP chamber on your unit, and if necessary, replace it with insulated DAP chamber. 2. Siemens service organization will contact you shortly to arrange a date to perform this corrective action. 3. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418
Distribution
- Distribution pattern
- IL, NE
Timeline
- Recall initiated
- 2019-06-20
- Terminated
- 2020-04-17
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #174336. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.