Signa Openspeed 0.7T MR Systems, Model Numbers: Openspeed 3 (2138300-30), Openspeed 4 (2377062-5), Openspeed 5 (2377062-5, 2377062-30)
This recall has been terminated (originally issued August 25, 2009).
- Company
- Ge Medical Systems, Llc
- Recall Initiated
- November 3, 2008
- Posted
- August 25, 2009
- Terminated
- May 24, 2012
- Recall Number
- Z-1723-2009
- Quantity
- 170(156 US / 14 OUS)
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
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
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 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.
Lot / Code Info
Model Number: 2138300-30; Serial Numbers: 00000203387MR6, 00000208208MR9, 00000216409MR3, 00000229302MR5, 00000229306MR6, 00000230309MR7, 00000231588MR5, 00000237930MR3, 00000239847MR7, 00000241694MR9, 00000247255MR3, 00000253103MR6, 00000189633MR1, 00000192104MR8, 00000193652MR5, 00000194218MR4, 00000194219MR2, 00000194950MR2, 00000196364MR4, 00000197334MR6, 00000198709MR8, 00000199443MR3, 00000201708MR5, 00000201709MR3, 00000201710MR1, 00000201901MR6, 00000202223MR4, 00000203386MR8, 00000204837MR9, 00000204838MR7, 00000204839MR5, 00000206438MR4, 00000206439MR2, 00000207493MR8, 00000207494MR6, 00000208209MR7, 00000208210MR5, 00000209712MR9, 00000209713MR7, 00000212511MR0, 00000212513MR6, 00000212514MR4, 00000212515MR1, 00000215366MR6, 00000216405MR1, 00000216406MR9, 00000216407MR7, 00000216409MR3, 00000217198MR1, 00000217201MR3, 00000221250MR4, 00000221251MR2, 00000221253MR8, 00000221254MR6, 00000222950MR8, 00000225273MR2, 00000225274MR0, 00000225942MR2, 00000226318MR4, 00000228022MR0, 00000228023MR8, 00000228024MR6, 00000228773MR8, 00000229303MR3, 00000229304MR1, 00000229305MR8, 00000230308MR9, 00000230312MR1, 00000231591MR9, 00000231592MR7, 00000232328MR5, 00000233644MR4, 00000233646MR9, 00000234832MR4, 00000234833MR2, 00000234834MR0, 00000237051MR8, 00000237052MR6, 00000237053MR4, 00000237926MR1, 00000237927MR9, 00000237928MR7, 00000237929MR5, 00000239480MR7, 00000239482MR3, 00000239483MR1, 00000239484MR9, 00000239845MR1, 00000239846MR9, 00000241126MR2, 00000241127MR0, 00000241693MR1, 00000241695MR6, 00000243405MR8, 00000244231MR7, 00000244232MR5, 00000247252MR0, 00000247253MR8, 00000247254MR6, 00000247256MR1, 00000250184MR9, 00000250185MR6, 00000250186MR4, 00000250187MR2, 00000253039MR2, 00000253102MR8, Unknown; Model Number: 2377062-5; Serial Numbers: 00000000100YR8, 00000000119YR8, 00000000129YR7, 00000000102YR4, 00000000103YR2, 00000000105YR7, 00000000106YR5, 00000000108YR1, 00000000109YR9, 00000000111YR5, 00000000113YR1, 00000000118YR0, 00000000120YR6, 00000000122YR2, 00000000124YR8, 00000000127YR1, 00000000128YR9, 00000000131YR3, 00000000132YR1, 00000000133YR9, 00000000134YR7, 00000000135YR4, 00000000136YR2, 00000000137YR0, 00000000142YR0, 00000000144YR6, 00000000146YR1, 00000000149YR5, 00000000150YR3, 00000000151YR1, 00000000152YR9, 00000000155YR2, 00000943610YM6, 00000951021YM5, 00000962592YM2; Model Number: 2377062-30 Serial Numbers: 00000003047YR8, 00000003011YR4, 00000003022YR1, 00000003023YR9, 00000003024YR7, 00000003025YR4, 00000003026YR2, 00000003027YR0, 00000003028YR8, 00000003029YR6, 00000003030YR4, 00000003031YR2, 00000003033YR8, 00000003034YR6, 00000003035YR3, 00000003036YR1, 00000003039YR5, 00000003041YR1, 00000003042YR9, 00000003043YR7 and 00000003044YR5.
Root Cause
Device Design
Action Taken
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.