Company: GE Healthcare, LLC
Date of Enforcement Report: 10/23/2013
Class ll:
PRODUCT
GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.Recall Number Z-0023-2014
REASON
GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some PACS may combine series under a patient using only the Series UID, although all images are correctly annotated. This issue can cause additional images from a different patient and images from two or more patients to appear in one exam.
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI on 3/26/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
380
DISTRIBUTION
Nationwide and Internationally
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