GE 1.5T and 3.0T Signa HDX MR System Model Number(s): 2226300, 2377062-61, 2395001, 2395001-2, 5107849, and 5127452. Thi
FDA device recall Z-2225-2008 · posted 2008-09-11 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- Possible misdiagnosis or inappropriate treatment based on the image. Signal homogeneity may be affected when BRAVO applications are set with IR Prep off. The concern is that signal inhomogeneity can result in an erroneous diagnosis.
- Action taken
- Customer Letter and Operator Manual addendum were sent directly to customers in August 2008. When the software correction is issued, GE Field Engineer will visit each site to implement the correction. (Not conducted yet)
- Root cause
- Software change control
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 720 units (360 US / 360 OUS) estimate
- Distribution
- AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS,MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA,WI, and WV. Countries of A
- Date initiated
- 2008-03-28
- Date posted
- 2008-09-11
- Date terminated
- 2011-12-17
- 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 |
|---|---|---|
| GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM (K052293) | Ge Medical Systems, LLC | 2005-09-21 |