GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.
FDA device recall Z-2241-2013 · posted 2013-09-18 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has become aware that when analyzing fMRI images using the READY View application software, incorrect fMRI activation maps may be computed and displayed.
- Action taken
- GE provided Urgent Medical Device Correction letters to consignees in the following countries: Canada, Finland, France, Germany, Guadeloupe, Italy, Japan, Latvia, Martinique, Netherlands, Norway, Poland, Reunion, Romania, Saudi Arabia, Singapore, Spain,Sweden, Switzerland, Turkey and the United Kingdom. The letters were dated March 27, 2012 and were addressed to Hospital Administrators, Radiology Mangers and Risk Managers. The letters described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (US 800-437-1171, Japan 0120-055-919 and for other countries contact your local GE Healthcare Service Representative). *Letters to other consignees is being planned for September 2013.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 318 (28 USm 290 OUS)
- Distribution
- Worldwide Distribution-USA including the states of IL, MN, NJ, NY, and VA, and the countries of ALGERIA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, DENMARK, FINLAND, FRANCE, GERMANY, GUADELOUPE, INDIA, INDON
- Date initiated
- 2012-03-27
- Date posted
- 2013-09-18
- Date terminated
- 2014-11-21
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| READY VIEW (K110573) | Ge Healthcare (Ge Medical Systems Scs) | 2011-05-03 |