Company:GE Medical Systems
Date of Enforcement Report 4/22/2009
Class:ll
PRODUCT
a) GE Healthcare Infinia, Model Numbers: a) ASM000886, b) ASM001333, c) ASM001391, d) ASM001465, e) ASM001473, f) ASM001620, g) ASM500016, h) H3000WM, i) H3000WT, j) H3000WY and k) SYS000041. Product is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications, Recall # Z-1001-2009;
b) GE Healthcare Infinia Hawkeye, Model Numbers: a) H3000WR, b) H3000WW, c) H3000WZ, d) H3000YM and e) H3000YS. Product is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications, Recall # Z-1002-2009;
c) GE Healthcare Infinia Hawkeye 4, Model Numbers: a) 5178728, b) ASM500060, c) H3000WC and d) H3000WD. Product is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications, Recall # Z-1003-2009
REASON
GE Healthcare has recently become aware of excessive pressure applied by the collimator pressure sensitive cover of Infinia (Infinia, Infinia Hawkeye, Infinia Hawkeye 4) that may impact patient safety. It was reported at a customer site that the pressure used to activate the Pressure Sensitive Device (PSD) should be lowered and that the body contouring software requires correction to prevent possible patient injury during operation. This resulted in a patient receiving a broken nose during a whole body scan while using the Auto Body Contour software option.
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Medical Systems, LLC, Waukesha , WI , by letter dated April 2008.
Manufacturer: GE Medical System, Tirat Hacarmel 30200 , Israel . Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1,256 units
DISTRIBUTION
Nationwide and Internationally
