Company:Blood Bank Computer Systems, Inc .
Date of Enforcement Report 4/17/2013
Class ll:
PRODUCT
GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1, R1.0.2 and R1.0.3) diagnostic ultrasound system with the S4-10-D Ultrasound Probe. The device is intended for use in ultrasound evaluation. Recall Number Z-1096-2013
REASON
GE Healthcare has become aware of a potential safety issue due to the S4-10-D Ultrasound Probe used in conjunction with the LOGIQ S8 and LOGIQ S7 Ultrasound systems. It was also discovered that this issue also leads to a specification issue of the acoustic output of this probe. There is a potential for a skin burn when the flow model in the cardiac application is activated with the S4-10-D Ultrasound probe.
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI on 2/8/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2061
DISTRIBUTION
Nationwide and Internationally
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