Company:GE Healthcare LLC.
Date of Enforcement Report 6/2/2010
Class:ll
PRODUCT
1) GE Healthcare, Innova 4100 IQ: GE Innova 4100 / 4100 IQ, Cardiovascular Imaging System (The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Recall # Z-1659-2010;
2) GE Healthcare, Innova 3100 IQ: GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, (The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Recall # Z-1660-2010;
3) GE Healthcare, Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Recall # Z-1661-2010
REASON
A potential software failure related to the Worklist functionality has been identified on a subset of Innova 2100IQ, 3100IQ and 4100IQ systems. When using the Worklist function to import patient data to Innova, there are two scenarios that will cause the next exam to fail and the inability to recall acquired sequences.
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letter dated March 23, 2010.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
195 units
DISTRIBUTION
Nationwide and Internationally
