Recall Z-1533-2014 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare, LLC
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.
| Date | May 1, 2014 (initiated Apr 23, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process design |
| 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 custom |
| Quantity | 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, CANADA, CAYMAN ISLANDS, CHINA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, FRENCH PO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081028 | SIGNA 3.0T MR750 SYSTEM Ge Medical Systems, LLC, Apr 25, 2008 |
| K083147 | DISCOVERY MR450 Ge Medical Systems, LLC, Nov 4, 2008 |
| K091536 | OPTIMA MR450W Ge Medical Systems, LLC, Jul 17, 2009 |
| K103327 | DISCOVERY MR750W 3.0T Ge Healthcare Japan Corporation, Sep 30, 2011 |
| K103335 | GEM OPTION FOR 1.5 MRI SYSTEMS GE Healthcare, Mar 7, 2011 |