GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations. Product Usage: The i

FDA device recall Z-1279-2015 · posted 2015-03-13 · Terminated

Recall details

Recalling firm

GE Healthcare

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

Action taken

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

Status

Terminated

Product code

KPS

Quantity 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 o

Date initiated

2015-03-05

Date posted

2015-03-13

Date terminated

2015-08-17

Location

Waukesha, WI

Related 510(k) clearances