Recall Z-1722-2009 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Medical Systems, LLC
GE Healthcare Signa Ovation 0.35T, Model Numbers: Ovation 1-3 (2276937), Ovation 4 (2377062-2, 2377062-5, 2377062-8, or 5118172), and Ovation 5 (5148725). The 0.35T Signa Ovation with Excite Magnetic Resonance system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The 0.35T Signa Ovation with Excite Magnetic Resonance system is indicat
| Date | Aug 25, 2009 (initiated Nov 3, 2008) |
| Status | Terminated |
| Reason | GE Healthcare has identified a potential pinch point hazard on Ovation MR Scanner when using CTL Array XL Body Flex and Opened Body coil. A patient's hand may be pinched between the magnet bore ceiling cover and the CTL Array, XL Body Flex, or Open Body coil if the patient puts his/her hand on the top of the coil. 2/20/09: Recall being expanded to include the OpenSpeed Systems. |
| Root cause | Device Design |
| Action | GE Healthcare issued a "Product Safety Notification" letter dated October 23, 2008. The letter was addressed to Hospital Administrators, Mangers of Radiology/Cardiology & Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product, Safety Instructions, Product Correction and Contact Information for the Signa Ovation 0.35T Systems. A second GE Healthcare "Urgent Medical Device Correction" letter dated March 5, 2009 was sent 3/9/09 to consignees which addressed the expanded recall to the Signa OpenSpeed0.7T MR Systems. For further questions, contact your local GE Heal |
| Quantity | 308 (143 US / 142 OUS / 23 TBD) |
| Distribution | Worldwide Distribution-- US (including states of AL, ALZ, AR, CA, CO,CT, DE, FL, FA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MT, MO, NE,NH, NV, NJ, NY, NC, OH, OK, OR, PA, PR, SC SD, TN, TX, VA, WA, WV and WI), CHINA, CYPRUS, ARGENTINA, BRAZIL EGYPT, DENMARK, FEDERAL REPUBLIC OF GERMANY, FEDERAL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053009 | GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM GE Medical Systems, Nov 17, 2005 |