GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR7

FDA device recall Z-1533-2014 · posted 2014-05-01 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

GE Healthcare has recently become aware of a potential safety issue with certain GE MRI Products. Patient egress from the system can be delayed or impeded if the cradle release handle and/or cradle release block mechanism malfunctions or becomes misaligned. This could make the safe removal of the patient from the system difficult.

Action taken

Consignees were sent on 4/23/2014 a GE Healthcare Ref # 60863 "Urgent Medical Device Correction" letter dated April 18, 2014. The letter was addressed to Hospital Administrators / Risk Mangers, Radiology Department Mangers and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and Contact Information. If customers encounter the stated problem with the device, they should contact their GE Healthcare Service Representative for an inspection and necessary repairs. GE will correct all affected devices at no cost to the customers. For questions customers should contact their local service representative.

Root cause

Process design

Status

Terminated

Product code

LNH

Quantity affected

1,548 units (704 US, 844 OUS).

Distribution

Worldwide Distribution -- USA, except ND, RI and WY, and including DC, Guam, and Puerto Rico; and, the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA,AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL

Date initiated

2014-04-23

Date posted

2014-05-01

Date terminated

2015-01-21

Location

Waukesha, WI

Related 510(k) clearances