Discovery MR450 The systems are whole body magnetic resonance scanners designed to support high resolution, high signal-

FDA device recall Z-1188-2017 · posted 2017-02-10 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

Potential safety issue with the patient bore heating on the Discovery MR450 narrow bore 1.5T MRI. In the event of a RF component failure, typically happening after extended system use, a small area on the bore surface may become warmer than normal. If this happens in an area where there is patient contact with the bore, and proper padding is not used, it may cause a serious burn.

Action taken

The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter GEHC Ref# 60913 Dated January 20, 2017. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction & Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Root cause

Device Design

Status

Terminated

Product code

LNH

Quantity affected

60

Distribution

Worldwide Distribution- US (nationwide) including states of: CA, DC, IL, MN, MO, NY, SC, TX, WI, WV; and countries of: Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Netherlands, No

Date initiated

2017-01-20

Date posted

2017-02-10

Date terminated

2019-09-24

Location

Waukesha, WI

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