Recall Z-1279-2015— GE Healthcare

Name: FDA recall Z-1279-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-05

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, initiated 2015-03-05, terminated 2015-08-17. It names one FDA 510(k) clearance: K953801. Product: GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations. Product Usage: The intended use of the system is 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.. Reason: GE Healthcare has recently become aware of a potential safety issue due to a collimator falling off a VG system during a Quality Control check, while the detectors were rotating. No injuries have been reported to date.

Recalling firm: GE Healthcare
Classification: Class II
Status: Terminated
Initiated: 2015-03-05
Terminated: 2015-08-17
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K953801 — VARICAMElscint, Inc.·cleared 1995-11-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations. Product Usage: The intended use of the system is 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.

Reason for recall

GE Healthcare has recently become aware of a potential safety issue due to a collimator falling off a VG system during a Quality Control check, while the detectors were rotating. No injuries have been reported to date

Data sourced from openFDA. This site is unofficial and independent of the FDA.