GE Discovery VCT, Volume PET-CT scanner, Model 5124069-3.
FDA device recall Z-0806-2007 · posted 2007-05-15 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis.
- Action taken
- A Field Modification Instruction was issued to the field to inspect all systems and replace the tube window screws and the window filter, as well as clean any traces of oil in the tube window area. A 12/21/2006, Urgent Product Correction Notice/Customer letter has also been distributed informing the customers of the safety issue and the product correction.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 4
- Distribution
- Worldwide Distribution: USA in the following states and locations: AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, N
- Date initiated
- 2006-12-21
- Date posted
- 2007-05-15
- Date terminated
- 2012-07-03
- Location
- Waukesha, WI
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE DISCOVERY VCT SYSTEM (K050559) | GE Medical Systems | 2005-03-17 |