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 indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique image Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique image
Brand
GE Medical Systems, LLC
Lot Codes / Batch Numbers
Model Number: 2276937, Serial Numbers: 00000869965YM4, 00000801207YM2, 00000813952YM9, 00000952559YM3, 00000236062MR6, 00000869966YM2, 00000801206YM4, 00000813945YM3, 00000813950YM3, 00000869958YM9, 00000952561YM9, 00000813958YM6, 00000919518YM1, 00000813944YM6, 00000837353YM2, 00000813960YM2, 00000837350YM8, 00000264247MR1, 00000897708YM4, 00000897716YM7, 00000919512YM4, 00000919526YM4, 00000026540VE5, 00000919509YM0, 00000813959YM4, 00000801204YM9, 00000813947YM9, 00000952560YM1, 00000952565YM0, 00000897711YM8, 00000897717YM5, 00000919515YM7, 00000952552YM8, 00000813951YM1, 00000897701YM9, 00000869949YM8, 00000837359YM9, 00000919519YM9, 00000813946YM1, 00000869956YM3, 00000897706YM8, 00000952563YM5, 00000869947YM2, 00000801199YM1, 00000801193YM4, 00000837362YM3, 00000952548YM6, 00000952549YM4, 00000837360YM7, 00000952547YM8, 00000837346YM6, 00000869952YM2, 00000869954YM8, 00000919514YMO, 00000919524YM9, 00000837358YM1, 00000919521YM5, 00000869962YM1, 00000919513YM2, 00000897705YM0, 00000952555YM1, 00000813943YM8, 00000869961YM3, 00000813956YM0, 00000801203YM1, 00000801208YM0, 00000801209YM8, 00000813948YM7, 00000813953YM7, 00000813954YM5, 00000837347YM4, 00000837351YM6, 00000837352YM4, 00000837354YM0, 00000837357YM3, 00000837361YM5, 00000837363YM1, 00000837364YM9, 00000837365YM6, 00000869950YM6, 00000869951YM4, 00000869953YM0, 00000869955YM5, 00000869957YM1, 00000869960YM5, 00000869963YM9, 00000897698YM7, 00000897699YM5, 00000897700YM1, 00000897702YM7, 00000897703YM5, 00000897704YM3, 00000897707YM6, 00000897715YM9, 00000919507YM4, 00000919510YM8, 00000919516YM5, 00000919517YM3, 00000919520YM7, 00000919523YM1, 00000952550YM2, 00000952553YM6, 00000952557YM7, 00000952558YM5, 00000952562YM7, 00000952566YM8, 00000952554YM4, 00000919511YM6, 00000869948YM0, 00000897714YM2, 00000813957YM8, 00000813955YM2, 00000897712YM6, 00000813949YM5, Model Number: 5118172, Serial Numbers, 00000000564YR5, 00000000565YR2, 00000000563YR7, 00000000561YR1, Model Number: 2377062-2, Serial Number: 00000963007YM0, Model Number: 2377062-5, Serial Numbers: 00000000120YR6, 00000000123YR0, 00000000132YR1, 00000000124YR8, 00000000137YR0, 00000000130YR5, 00000000134YR7, 00000000138YR8, 00000962592YM2, 00000000146YR1, 00000000117YR2, 00000000116YR4, 00000000118YR0, 00000943610YM6, 00000000152YR9, 00000000140YR4, 00000000110YR7, 00000000135YR4, 00000000106YR5, 00000000129YR7, 00000000141YR2, 00000000125YR5, 00000000142YR0, 00000000113YR1, 00000000150YR3, 00000000105YR7, 00000000131YR3, 00000000139YR6, 00000000155YR2, 00000000108YR1, 00000000143YR8, 00000000101YR6, 00000000109YR9, 00000000153YR7, 00000951021YM5, 00000000119YR8, 00000000136YR2, 00000000128YR9, 00000000100YR8, 00000000112YR3, 00000000121YR4, 00000000154YR5, Model Number: 2377062-8, Serial Numbers: 00000000776YR5, 00000000792YR2, 00000000793YR0, 00000000801YR1, 00000000803YR7, 00000000829YR2, 00000000836YR7, 00000000758YR3, 00000000765YR8, 00000000755YR9, 00000000756YR7, 00000000774YR0, 00000000784YR9, 00000000785YR6, 00000000798YR9, 00000000827YR6, 00000000816YR9, 00000000779YR9, 00000000828YR4, 00000000789YR8, 00000000838YR3, 00000000773YR2, 00000000788YR0, 00000000796YR3, 00000000763YR3, 00000000766YR6, 00000000767YR4, 00000000787YR2, 00000000790YR6, 00000000800YR3, 00000000834YR2, 00000000840YR9, 00000000830YR0, 00000000832YR6, 00000000786YR4, 00000000764YR1, 00000000775YR7, 00000000818YR5, 00000000768YR2, 00000000757YR5, 00000000760YR9, 00000000762YR5, 00000000783YR1, 00000000809YR4, 00000000782YR3, 00000000812YR8, 00000000826YR8, 00000000835YR9, 00000000770YR8, 00000000771YR6, 00000000825YR0, 00000000759YR1, 00000000821YR9, 00000000841YR7, 00000000831YR8, 00000000808YR6, 00000000823YR5, 00000000824YR3, 00000000772YR4, 00000000810YR2, 00000000837YR5, 00000000769YR0, 00000000815YR1, 00000000833YR4, 00000000804YR5, 00000000778YR1, 00000000780YR7, 00000000795YR5, 00000000799YR7, 00000000805YR2, 00000000807YR8, 00000000819YR3, 00000000839YR1, 00000000811YR0, 00000000761YR7, 00000000777YR3, 00000000781YR5, 00000000791YR4, 00000000797YR1, 00000000794YR8, and Model Number: 5148725, Serial Numbers: 00000154413HM9, 00000176551HM0, 00000139846HM0, 00000192389HM5, 00000177143HM5, 00000193109HM6, 00000148905HM3, 00000147526HM8, 00000138166HM4, 00000000SPI275, 00000188489HM9, 00000167482HM9, 00000169104HM7, 00000171692HM7, 00000157419HM3, 00000266430MR8, 00000155516HM8, 00000155515HM0, 00000160809HM0, 00000175023HM1, 00000150718HM5, 00000162563HM1, 00000164072HM1, 00000165772HM5, 00000172421HM0, 00000172816HM1, 00000172869HM0, 00000173908HM5, 00000177792HM9, 00000178519HM5, 00000179361HM1, 00000180127HM3, 00000180746HM0, 00000182071HM1, 00000182249HM3, 00000182597HM5, 00000183130HM4, 00000187365HM2, 00000188810HM6, 00000189105HM0, 00000191017HM3, 00000191154HM4, 00000196647HM2, 00000200577HM5, 00000265078MR6, 00000157418HM5, 00000174348HM3, 00000189943HM4, 00000181736HM0, 00000146891HM7, 00000158641HM1, 00000147906HM2, 00000169833HM1, 00000170940HM1, 00000190359HM0, 00000191544HM6, 00000193220HM1, 00000193936HM2, 00000195772HM9, 00000144797HM8, 00000150152HM7, 00000170109HM3, 00000181735HM2, 00000197645HM5, 00000168323HM4 and 00000181517HM4.
Products Sold
Model Number: 2276937; Serial Numbers: 00000869965YM4, 00000801207YM2, 00000813952YM9, 00000952559YM3, 00000236062MR6, 00000869966YM2, 00000801206YM4, 00000813945YM3, 00000813950YM3, 00000869958YM9, 00000952561YM9, 00000813958YM6, 00000919518YM1, 00000813944YM6, 00000837353YM2, 00000813960YM2, 00000837350YM8, 00000264247MR1, 00000897708YM4, 00000897716YM7, 00000919512YM4, 00000919526YM4, 00000026540VE5, 00000919509YM0, 00000813959YM4, 00000801204YM9, 00000813947YM9, 00000952560YM1, 00000952565YM0, 00000897711YM8, 00000897717YM5, 00000919515YM7, 00000952552YM8, 00000813951YM1, 00000897701YM9, 00000869949YM8, 00000837359YM9, 00000919519YM9, 00000813946YM1, 00000869956YM3, 00000897706YM8, 00000952563YM5, 00000869947YM2, 00000801199YM1, 00000801193YM4, 00000837362YM3, 00000952548YM6, 00000952549YM4, 00000837360YM7, 00000952547YM8, 00000837346YM6, 00000869952YM2, 00000869954YM8, 00000919514YMO, 00000919524YM9, 00000837358YM1, 00000919521YM5, 00000869962YM1, 00000919513YM2, 00000897705YM0, 00000952555YM1, 00000813943YM8, 00000869961YM3, 00000813956YM0, 00000801203YM1, 00000801208YM0, 00000801209YM8, 00000813948YM7, 00000813953YM7, 00000813954YM5, 00000837347YM4, 00000837351YM6, 00000837352YM4, 00000837354YM0, 00000837357YM3, 00000837361YM5, 00000837363YM1, 00000837364YM9, 00000837365YM6, 00000869950YM6, 00000869951YM4, 00000869953YM0, 00000869955YM5, 00000869957YM1, 00000869960YM5, 00000869963YM9, 00000897698YM7, 00000897699YM5, 00000897700YM1, 00000897702YM7, 00000897703YM5, 00000897704YM3, 00000897707YM6, 00000897715YM9, 00000919507YM4, 00000919510YM8, 00000919516YM5, 00000919517YM3, 00000919520YM7, 00000919523YM1, 00000952550YM2, 00000952553YM6, 00000952557YM7, 00000952558YM5, 00000952562YM7, 00000952566YM8, 00000952554YM4, 00000919511YM6, 00000869948YM0, 00000897714YM2, 00000813957YM8, 00000813955YM2, 00000897712YM6, 00000813949YM5; Model Number: 5118172; Serial Numbers; 00000000564YR5, 00000000565YR2, 00000000563YR7, 00000000561YR1; Model Number: 2377062-2; Serial Number: 00000963007YM0; Model Number: 2377062-5; Serial Numbers: 00000000120YR6, 00000000123YR0, 00000000132YR1, 00000000124YR8, 00000000137YR0, 00000000130YR5, 00000000134YR7, 00000000138YR8, 00000962592YM2, 00000000146YR1, 00000000117YR2, 00000000116YR4, 00000000118YR0, 00000943610YM6, 00000000152YR9, 00000000140YR4, 00000000110YR7, 00000000135YR4, 00000000106YR5, 00000000129YR7, 00000000141YR2, 00000000125YR5, 00000000142YR0, 00000000113YR1, 00000000150YR3, 00000000105YR7, 00000000131YR3, 00000000139YR6, 00000000155YR2, 00000000108YR1, 00000000143YR8, 00000000101YR6, 00000000109YR9, 00000000153YR7, 00000951021YM5, 00000000119YR8, 00000000136YR2, 00000000128YR9, 00000000100YR8, 00000000112YR3, 00000000121YR4, 00000000154YR5; Model Number: 2377062-8; Serial Numbers: 00000000776YR5, 00000000792YR2, 00000000793YR0, 00000000801YR1, 00000000803YR7, 00000000829YR2, 00000000836YR7, 00000000758YR3, 00000000765YR8, 00000000755YR9, 00000000756YR7, 00000000774YR0, 00000000784YR9, 00000000785YR6, 00000000798YR9, 00000000827YR6, 00000000816YR9, 00000000779YR9, 00000000828YR4, 00000000789YR8, 00000000838YR3, 00000000773YR2, 00000000788YR0, 00000000796YR3, 00000000763YR3, 00000000766YR6, 00000000767YR4, 00000000787YR2, 00000000790YR6, 00000000800YR3, 00000000834YR2, 00000000840YR9, 00000000830YR0, 00000000832YR6, 00000000786YR4, 00000000764YR1, 00000000775YR7, 00000000818YR5, 00000000768YR2, 00000000757YR5, 00000000760YR9, 00000000762YR5, 00000000783YR1, 00000000809YR4, 00000000782YR3, 00000000812YR8, 00000000826YR8, 00000000835YR9, 00000000770YR8, 00000000771YR6, 00000000825YR0, 00000000759YR1, 00000000821YR9, 00000000841YR7, 00000000831YR8, 00000000808YR6, 00000000823YR5, 00000000824YR3, 00000000772YR4, 00000000810YR2, 00000000837YR5, 00000000769YR0, 00000000815YR1, 00000000833YR4, 00000000804YR5, 00000000778YR1, 00000000780YR7, 00000000795YR5, 00000000799YR7, 00000000805YR2, 00000000807YR8, 00000000819YR3, 00000000839YR1, 00000000811YR0, 00000000761YR7, 00000000777YR3, 00000000781YR5, 00000000791YR4, 00000000797YR1, 00000000794YR8; and Model Number: 5148725; Serial Numbers: 00000154413HM9, 00000176551HM0, 00000139846HM0, 00000192389HM5, 00000177143HM5, 00000193109HM6, 00000148905HM3, 00000147526HM8, 00000138166HM4, 00000000SPI275, 00000188489HM9, 00000167482HM9, 00000169104HM7, 00000171692HM7, 00000157419HM3, 00000266430MR8, 00000155516HM8, 00000155515HM0, 00000160809HM0, 00000175023HM1, 00000150718HM5, 00000162563HM1, 00000164072HM1, 00000165772HM5, 00000172421HM0, 00000172816HM1, 00000172869HM0, 00000173908HM5, 00000177792HM9, 00000178519HM5, 00000179361HM1, 00000180127HM3, 00000180746HM0, 00000182071HM1, 00000182249HM3, 00000182597HM5, 00000183130HM4, 00000187365HM2, 00000188810HM6, 00000189105HM0, 00000191017HM3, 00000191154HM4, 00000196647HM2, 00000200577HM5, 00000265078MR6, 00000157418HM5, 00000174348HM3, 00000189943HM4, 00000181736HM0, 00000146891HM7, 00000158641HM1, 00000147906HM2, 00000169833HM1, 00000170940HM1, 00000190359HM0, 00000191544HM6, 00000193220HM1, 00000193936HM2, 00000195772HM9, 00000144797HM8, 00000150152HM7, 00000170109HM3, 00000181735HM2, 00000197645HM5, 00000168323HM4 and 00000181517HM4.
GE Medical Systems, LLC is recalling GE Healthcare Signa Ovation 0.35T, Model Numbers: Ovation 1-3 (2276937), Ovation 4 (2377062-2, 23770 due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AR, CA, CO, CT, DE, FL, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WV, WI, PR
Page updated: Jan 10, 2026