GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Ver
FDA device recall Z-1960-2012 · posted 2012-07-09 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT and PET images associated with the CT/PET fusion capabilities of your Volume Viewer and CT/PET Fusion application. Volume Viewer allows two studies (one PET and one CT) that are registered in the same spatial domain to be viewed simultaneously in fused mode. The two images should be aligned to th
- Action taken
- GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 23, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter provides safety instructions for customers to use until a software upgrade is available. Contact the firm at 800-437-1171 for questions regarding this recall.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 70
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of CA, FL, IL, MA, NJ, NY, SC, and TX and the countries of TURKEY, TUNISIA, TAIWAN, SPAIN, SINGAPORE, SAUDI ARABIA, RUSSIAN FEDERATION, KEN
- Date initiated
- 2012-05-24
- Date posted
- 2012-07-09
- Date terminated
- 2012-12-06
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CT COLONOGRAPHY/NAVIGATOR2 (K012313) | Ge Medical Systems, Inc. | 2001-08-07 |
| ADVANTAGE WINDOWS CT/PET FUSION (K010336) | Ge Medical Systems, Inc. | 2001-02-16 |