Recalls / —
—#51936
Product
Definium AMX 700 Digital mobile x-ray system, GE Healthcare 3000 North Grandview Waukesha, WI
- FDA product code
- IZL — System, X-Ray, Mobile
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K052897
- Affected lot / code info
- 973971AMXD1, 973971AMXD2, 402449CDP1, 402449CDP2, 601426DAMX1, and 972566D700A
Why it was recalled
When using the Tech Switch on exposures >750ms, >100 kVp and > 100 mAs the exposure terminates prematurely.
Root cause (FDA determination)
Other
Action the firm took
Visit to each consignee beginning December 21, 2006.
Recalling firm
- Firm
- GE Medical Systems LLC
- Address
- 3200 N Grandview Blvd, Waukesha, Wisconsin 53188-1693
Distribution
- Distribution pattern
- Product was distributed in the following states: MS, NE, NJ, and, TX
Timeline
- Recall initiated
- 2006-12-21
- Posted by FDA
- 2007-05-22
- Terminated
- 2008-02-24
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #51936. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.