GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.
Reported: September 25, 2013 Initiated: March 27, 2012 #Z-2241-2013
Product Description
GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.
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.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units 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, INDONESIA, ISRAEL, ITALY, JAPAN,KOREA, LATVIA, MARTINIQUE, NETHERLANDS, NORWAY, PHILIPPINES,S POLAND, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, and VIETNAM.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.. Recalled by GE Healthcare, LLC. Units affected: 318 (28 USm 290 OUS).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 25, 2013. Severity: Moderate. Recall number: Z-2241-2013.
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