Company:GE Healthcare, LLC
Date of Enforcement Report 1/11/12
Class ll:
PRODUCT
GE LOGIQ E9 Diagnostic Ultrasound Systems running software versions R3.1.0 and R3.1.1. 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; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical). Recall # Z-0705-2012
REASON
GE Healthcare has recently become aware of a potential safety issue associated with the data of your LOGIQ E9 system that may impact patient safety. 1 User may notice an image from a different patient, or an image from the current patient with title information from a different patient. 2 Incorrect measurements/calculations on images, when viewed on the off-line review station. As a result imaging may need to be repeated due to the confusion in the image information.
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letter dated December 20, 2011.
Manufacturer: GE Medical Systems Information Tecnology, Wauwatosa, WI. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
894 units
DISTRIBUTION
Nationwide and Internationally
