Recalls / —
—#41292
Product
Arcadis Varic Mobile X-Ray System
- FDA product code
- IZL — System, X-Ray, Mobile
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K042793
- Affected lot / code info
- Model number 8080017
Why it was recalled
Screws may become loose and fall into the OR field during surgery.
Root cause (FDA determination)
Other
Action the firm took
The recalling firm has their Service Engineers visiting each site to check the screws on the window and secure them with Loctite per Update Instructions SP022/05/S. The Service Engineer is also informing the account of the problem during the visits.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406
Distribution
- Distribution pattern
- The products were shipped nationwide to a distributor, a physician, and medical facilities
Timeline
- Recall initiated
- 2005-08-01
- Posted by FDA
- 2005-11-02
- Terminated
- 2006-07-19
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #41292. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.