Company: GE Healthcare It
Date of Enforcement Report: 11/6/2013
Class lI:
PRODUCT
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images may only be interpreted using an FDA approved monitor that offers at least 5 M pixel resolution and meets other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians an assistants.
Recall Number Z-0118-2014
REASON
Multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety risk to patients. These issues include: 1) With Auto-Fetch in use another patient’s image may appear without user’s intention. 2.a) In the case where dose administration time and image acquisition time fall on either side of midnight, the value will be under reported and close to zero for all pixel. 2.b) Decay correction tag (0054,1102) has a value “ADMIN” and the value reported will be exceedingly high. 2.c) In the “BQML” case where StartDateTime tag (0018,1078) is provided in place of StartTime (0018,1078) no value is reported and instead shows as “not calibrated”. 3) For multi-frame images that contain more than one overlay, studies with frames where overlays overlap, the wrong overlay is displayed. For studies with frames that should display one overlay for specified amount of frames and a second overlay for specified amount of frames, no overlays are displayed at all.
RECALLING FIRM/MANUFACTURER
GE Healthcare It, Barrington, IL on 6/15/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
847 units
DISTRIBUTION
Nationwide and Internationally
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