PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: March 25, 2015 Initiated: March 5, 2015 #Z-1279-2015

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

Details

Recalling Firm
GE Healthcare
Units Affected
472 (127 units US, 345 units OUS)
Distribution
Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, IA, LA, ME, MD, MA, MI, MN, MS, NE, NY, NC, OK, PA, PR, SD, TN, TX, VA, WA, WV, WI. and the countries of URUGUAY, UNITED KINGDOM,UKRAINE, TURKEY, THAILAND, TAIWAN, SWEDEN, SPAIN, SLOVAKIA, RUSSIA,PORTUGAL, POLAND, PERU, NORWAY, NETHERLANDS, MEXICO, REPUBLIC OF KOREA, JAPAN, ITALY, ISRAEL, INDIA, GREECE, GERMANY, FRANCE, ESTONIA, DENMARK, CZECH REPUBLIC, CYPRUS, COLOMBIA, CHINA, CANDA, BRAZIL, BELGIUM, AUSTRIA, AUSTRALIA, ARGENTINA.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by GE Healthcare. Units affected: 472 (127 units US, 345 units OUS).
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 25, 2015. Severity: Moderate. Recall number: Z-1279-2015.

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