Company: GE Healthcare, LLC
Date of Enforcement Report: 8/21/2013
Class ll:
PRODUCT
GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
Recall Number Z-1944-2013
REASON
GE Healthcare became aware of a potential issue related to incorrect image measurement associated with the software of the LOGIQ S8 system. This issue was found internally. Users may notice that the system shows incorrect image measurement results on Pulsed Wave (PW) or Time Intensity Curve (TIC) or depth measurement when using Virtual Convex mode and putting a cursor (Sample Volume, Depth measurement) near the edge of the image. As a result the cursor may need to be moved from near the edge of the image area.
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI on 8/13/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
755
DISTRIBUTION
Nationwide and Internationally
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