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Terminated

Signa Openspeed 0.7T MR Systems, Model Numbers: Openspeed 3 (2138300-30), Openspeed 4 (2377062-5), Openspeed 5 (2377062-5, 2377062-30)

FDA Recall Z-1723-2009 · Posted 2009-08-25

Recalling FirmGE Medical Systems, LLC
Recall StatusTerminated
Product CodeLNH
Date Initiated2008-11-03
Date Terminated2012-05-24
Product Quantity170(156 US / 14 OUS)

Reason for Recall

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. Two injuries and four complaints filed. 2/20/09: Recall being expanded to incl

Firm 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 Healthcare sales or service representative.

Root Cause

Device Design

Distribution Pattern

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 REPUBLIC OF FRANCE, GET 7 D CHINA, GREECE, HUNGARY, ITALY, IVORY COAST, JAPAN, KOREA, KUWAIT, MALAWI, MEXICO, OMAN, PANAMA, PHILIPPINES, RUSSIAN FEDERATION, SAUDI ARABIA, SPAIN , SWITZERLAND, TURKEY, UKRAINE, UNITED ARAB EMERITUS, UNITED KINGDOM and VENEZUELA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032795GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEMGe Medical Systems, LLC · 2003-10-08

Official Source

View FDA Recall →

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

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