Company: GE Medical Systems, LLC.
Date of Enforcement Report 12/23/2015
Class lI:
PRODUCT
GE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures.
Recall Number Z-0414-2016
REASON
GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems .
RECALLING FIRM/MANUFACTURER
GE Medical Systems, LLC, Waukesha, WI. on 11/13/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
45
DISTRIBUTION
Nationwide and Internationally
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