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Terminated

GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery MR750w equipped with the GEM option products. Affected devices are whole body magnetic resonance scanners indicated for use as a diagnostic imaging devices.

FDA Recall Z-1533-2014 · Posted 2014-05-01

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeLNH
Date Initiated2014-04-23
Date Terminated2015-01-21
Product Quantity1,548 units (704 US, 844 OUS).

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.

Firm Action

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

Distribution Pattern

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, CANADA, CAYMAN ISLANDS, CHINA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, KOREA, KUWAIT, LEBANON, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, OMAN, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, T UREY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, and VENEZUELA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103327DISCOVERY MR750W 3.0TGe Healthcare Japan Corporation · 2011-09-30K103335GEM OPTION FOR 1.5 MRI SYSTEMSGE Healthcare · 2011-03-07K091536OPTIMA MR450WGe Medical Systems, LLC · 2009-07-17K083147DISCOVERY MR450Ge Medical Systems, LLC · 2008-11-04K081028SIGNA 3.0T MR750 SYSTEMGe Medical Systems, LLC · 2008-04-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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