GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device.
FDA device recall Z-1208-2013 · posted 2013-05-01 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of over 126 slices may display a left-to-right image flip . In addition, the acquired sagittal images may be annotated with left-right location annotation revers
- Action taken
- GE Healthcare sent an "Important Product Information" letter dated June 8, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers should contact their local service representative for questions regarding this notice.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 822 (154 US; 668 OUS)
- Distribution
- Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, excluding the state of RI and the countries of Yugoslavia YEMEN Viet Nam Venezuela Uzbekistan Uruguay United Arab Emirates Tunisia
- Date initiated
- 2012-06-08
- Date posted
- 2013-05-01
- Date terminated
- 2014-11-03
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE 1.5T SIGNA HDE MR SYSTEM (K052978) | Ge Medical Systems, LLC | 2005-11-09 |