GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . scanner designed to support high res

FDA device recall Z-2291-2013 · posted 2013-09-27 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

GE Healthcare has recently become aware of a potential safety issue due to exposed yellow foam on the end bells of Discovery MR450, Discovery MR750, and Optima MR450w products. The yellow foam strip used between the end bell covers and patient bore of certain GE MR Products may extend past the surface of the covers. The foam itself is not hazardous. However, any fluid or body substance absorbed

Action taken

GE Healthcare sent and Urgent Medical Device Correction letter dated August 13, 2013, to all affected consignees. 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. Customers were instructed that the system may continue to be used as normal even with the yello foam protruding in the bore. Customers were told not to attempt to remove the yellow foam. Customers with questions were instructed to contact their local service representative if they have any questions concerning the notification. For questions regarding this recall call 262-513-4122.

Root cause

Component design/selection

Status

Terminated

Product code

LNH

Quantity affected

828 (443 US, 385 OUS)

Distribution

Worldwide Distribution USA including DC, all states except HI, ND, RI and WY and Internationally to Australia, Bahrain, Belarus, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt,

Date initiated

2013-08-13

Date posted

2013-09-27

Date terminated

2014-04-25

Location

Waukesha, WI

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