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.

FDA Recall Z-1279-2015 · Posted 2015-03-13

Recalling FirmGE Healthcare

Recall StatusTerminated

Product CodeKPS

Date Initiated2015-03-05

Date Terminated2015-08-17

Product Quantity472 (127 units US, 345 units OUS)

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

Firm Action

GE Healthcare sent an "Urgent Medical Device Correction" letter GEHC Ref# 40865 dated March 5, 2015. The letter was addressed to Managers of Nuclear Medecine, Hospital Administrators / Risk Managers and Managers of Radiology /Cardiology. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact in the United States: 1-800-437-1171. For other countries, contact your local GE Healthcare Service Representative.

Root Cause

Use error

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K953801VARICAMElscint, Inc. · 1995-11-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.