GE Healthcare, Optima MR450w 1.5T MR systems The GE Signa MR750 System is a whole body magnetic resonance scanner design

FDA device recall Z-1377-2011 · posted 2011-02-18 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

GE Healthcare has become aware that during certain service procedures, there is a potential for electric shock associated with the gradient cooling manifold hoses of your MR750, MR450, and MR450w MR systems that may impact service or maintenance personnel's safety. The gradient cooling manifolds used on the affected systems may contain electrically conductive hoses, which become live when the gra

Action taken

GE Healthcare sent an "Urgent Medical Device Correction" letter dated November 16, 2011, to all affected customers. The letter was addressed to Hospital Administrator / Risk Manger, Radiology Department Manager and Maintenance / Biomedical Engineering Department. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product correction and Contact Information. Customers were instructed to follow appropriate lockout/tagout (LOTO) procedures. Customers were instructed to contact GE Healthcare engineering at 843-687-7213 or 843-697-3009 for instructions on how to proceed. For questions concerning the notiifcaton customers were instructed to contact their local Support Engineer.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LNH

Quantity affected

68

Distribution

Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, LA, MD, MA, MI, MO, NV, NJ, NY, NC, OR, PA, SC, TN, TX, WA, WI. and the countries of AUSTRALIA, BRAZIL, CANADA, E

Date initiated

2010-11-18

Date posted

2011-02-18

Date terminated

2012-02-04

Location

Waukesha, WI

Related 510(k) clearances