GE Medical Systems, COMPAX 40E X-ray Systems, Models; 2208203, 2208205, 2244282, 2244284, 2225863, 2225864 , 2225865, 22
FDA device recall Z-0457-2010 · posted 2009-11-25 · Terminated
Recall details
- Recalling firm
- GE Medical Systems, LLC
- Reason for recall
- GE Healthcare has recently become aware that table lock safety features, which are provided with Compax 40E X-ray systems, are not always being utilized and has resulted in unintended lateral tabletop movement that may impact patient safety.
- Action taken
- Consignees in US and Canada were sent on July 31, 2009 a GE Healthcare "Urgent Medical device Correction" letter dated July 30, 2009. The letter was addressed to Hospital Administrators/ Risk mangers; Radiology Department Mangers; Radiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product correction, and Contact Information. The letter instructs customers that the table manual mechanical lock is provided with the system and should be engaged when loading or unloading patients to ensure the tabletop is stabilized and not moving. For the rest of the world, the customer letter was dated October 22, 2009 and was mailed October 30, 2009.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZZ
- Quantity affected
- 1046
- Distribution
- Worldwide Distribution -- USA, including states of AL, AK, AZ, AR, CA, CO, CT, DC,FL, GA, HI, ID, IL , IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH,NJ, NM, NY, NC, OH, OK OR, PA, SC, SD,
- Date initiated
- 2009-07-30
- Date posted
- 2009-11-25
- Date terminated
- 2016-05-19
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COMPAX MODEL 40, 400, 400T (K884930) | General Electric Co. | 1988-12-22 |