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Terminated

GE Signa OpenSpeed 0.7T MR System. The 0.7T Signa OpenSpeed with Excite Magnetic Resonance System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times.

FDA Recall Z-1557-2009 · Posted 2009-06-30

Recalling FirmGE Medical Systems, LLC
Recall StatusTerminated
Product CodeLNH
Date Initiated2009-04-16
Date Terminated2013-04-23
Product Quantity171

Reason for Recall

GE Healthcare has identified a potential safety issue with the Signa OpenSpeed and Signa Ovation MR Scanner tables that may impact patient safety. The table may begin lowering on its own while a patient is on the table. If this occurs while the table is in the magnet bore, the table may tilt and could result in patient injury. The patient's head or feet depending on patient orientation, may hit

Firm Action

GE Healthcare issued an "Urgent Medical Device Correction" letter dated April 16, 2009 addressed to Hospital Administrators, Mangers of Radiology/Cardiology and Radiologists/Cardiologists. The letter describes the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. A GE Healthcare Field Engineer will schedule a field visit to correct the device. Further questions or concerns may be addressed to GE Healthcare at 1-262-521-6681.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution -- US including PR and states of AL, AZ, AR, CA, CO,CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MN, MS, MO,MT, NV, NH, NE, NJ, NY, NC, OH, OK,OR, PA, SC, SD, TN, TX, VA, WA, WV, WI and countries of BRAZIL CHINA, DENMARK, EGYPT, ENGLAND, GERMANY, GUATEMALA, HUNGARY, ITALY, IVORY COAST, JAPAN, KOREA, KUWAIT, OMAN, MEXICO, OMAN, PHILIPPINES, RUSSIAN FEDERATION, SPAIN, SWITZERLAND, TURKEY, UNITED ARAB EMIRATES 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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