Company:GE Healthcare, LLC
Date of Enforcement Report 6/29/2011
Class ll:
PRODUCT
BrightSpeed Excel Select, BrightSpeed Edge Select ,BrightSpeed Elite Select and BrightSpeed Elite Computed Tomography X-ray systems with software version 09BW35.11 or 09HW30.4. The GE BrightSpeed Delight Series Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, for patients of all ages, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. Recall # Z-2214-2011
REASON
GE Healthcare has become aware of a potential set of circumstances that could cause X-ray continuation during an unexpected table stop on certain BrightSpeed systems (BrightSpeed Excel/Edge/Elite Select and BrightSpeed Elite Computed Tomography X-ray Systems ) if this event were to occur on your system, patient safety may be impacted.
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letters dated January 19, 2011 and March 11, 2011.
Manufacturers: Ge Hangwei Medical Systems Co., Ltd., Beijing, China;
Yokogawa Medical Systems, Ltd., Hino-Shi, Tokyo, Japan.
Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
479 units
DISTRIBUTION
Nationwide and Internationally
