PlainRecordsFDA · Medical device recall
Signa OpenSpeed… and 1 more product
- Date posted by the FDA
- Nov. 19, 2010
- Status
- Terminated
- Filed by
- GE Healthcare, LLC
- Reason
- If the lateral table adjustment crank handle breaks off, it has sufficient attractive force to the magnet and may result in patient injury.
- Distribution pattern
- Worldwide Distribution -- USA, including states of AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, LA, KS, KY, LA, MD, MA, MI, MN, MS,MO,MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WV, and WI and countries of VENEZUELA, ECUADOR, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, SPAIN, RUSSIAN FEDERATION, REPUBLIC OF KOREA, POLAND, PHILIPPINE,S OMAN, MEXICO, KUWAIT, JAPAN, ITALY, HUNGARY, GERMANY, EGYPT, DENMARK, CHILE, CHINA, and BRASIL.
2 products in this recall
Signa OpenSpeed…
- Product
- Signa OpenSpeed, 0.7T MR Systems (HFO3-5).
- Quantity
- 176
- Codes and lots
- 00000241692MR3 00000239483MR1 00000208209MR7 00000217199MR9 00000000155YR2 00000215365MR8 00000216405MR1 00000243405MR8 00000234832MR4 00000206438MR4 00000234833MR2 00000003024YR7 00000000149YR5 00000003011YR4 00000000102YR4 00000197334MR6 00000241694MR9 00000003042YR9 00000250185MR6 00000000128YR9 00000000113YR1 00000247253MR8 00000239847MR7 00000226319MR2 00000212515MR1 00000000142YR0 00000000105YR7 00000237052MR6 00000215364MR1 00000231592MR7 00000003026YR2 00000000108YR1 00000201710MR1 00000225942MR2 00000000110YR7 00000000135YR4 00000000153YR7 00000003036YR1 00000000109YR9 00000247256MR1 00000943610YM6 00000000131YR3 00000000101YR6 00000207493MR8 00000000127YR1 00000234834MR0 00000239484MR9 00000003030YR4 00000192104MR8 00000233646MR9 00000194218MR4 00000193652MR5 00000239482MR3 00000247254MR6 00000244231MR7 00000003022YR1 00000230312MR1 00000217202MR1 00000217198MR1 00000222950MR8 00000237053MR4 00000000111YR5 00000221250MR4 00000000144YR6 00000003051YR0 00000000133YR9 00000000151YR1 00000231590MR1 00000237927MR9 00000231588MR5 00000194219MR2 00000212514MR4 00000209713MR7 00000229303MR3 00000228024MR6 00000239846MR9 00000196364MR4 00000003025YR4 00000204837MR9 00000000119YR8 00002397929MR5 00000201709MR3 00000203386MR8 00000239480MR7 00000000118YR0 00000208210MR5 00000216409MR3 00000003039YR5 00000237930MR3 00000212513MR6 00000003034YR6 00000226318MR4 00000003023YR9 00000209712MR9 00000003050YR2 00000225273MR2 00000229306MR6 00000000129YR7 00000228022MR0 00000000136YR2 00000221253MR8 00000250187MR2 00000237928MR7 00000951021YM5 00000237926MR1 00000250184MR9 00000003027YR0 00000000146YR1 00000253104MR4 00000000132YR1 00000241127MR0 00000232328MR5 00000003035YR3 00000003044YR5 00000221254MR6 00000241695MR6 00000201901MR6 00000230308MR9 00000202223MR4 00000241693MR1 00000221251MR2 00000239845MR1 00000253103MR6 00000000150YR3 00000229304MR1 00000229305MR8 00000962592YM2 00000225274MR0 00000217201MR3 00000212511MR0 00000000120YR6 00000003041YR1 00000229302MR5 00000253039MR2 00000003033YR8 00000233644MR4 00000003029YR6 00000247255MR3 00000207494MR6 00000000106YR5 00000216406MR9 00000000103YR2 00000230309MR7 00000194950MR2 00000003031YR2 00000241126MR2 00000237051MR8 00000000134YR7 00000003043YR7 00000204839MR5 00000000100YR8 00000000152YR9 00000228023MR8 00000244232MR5 00000225941MR4 00000208211MR3 00000189633MR1 00000232329MR3 00000250186MR4 00000247252MR0 00000231591MR9 00000000122YR2 00000228773MR8 00000216407MR7 00000003047YR8 00000003049YR4 00000253102MR8 00000204838MR7 00000199443MR3 00000000137YR0 00000201708MR5 00000000124YR8 00000198709MR8 00000003028YR8 00000208208MR9 00000231589MR3
- Recall started
- Aug. 23, 2010
- Device type
- System, Nuclear Magnetic Resonance Imaging
- Root cause (FDA)
- Nonconforming Material/Component
- What the company told customers
- Consignees were sent on 8/23/10 a GE "Urgent Medical Device Correction" letter dated August 20, 2010. The letter was addressed to Hospital Administrators / Risk Mangers, Radiology Department Managers and Radiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction, and Contact Information. Customers were asked to discontinue use of their MR system and to contact their local service representative, if the lateral table adjustment crank handle on the table becomes loose.
- Recall number
- Z-0425-2011
Signa Ovation…
- Product
- Signa Ovation, 0.35T MR Systems (MFO 1-4). Indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the musculoskeletal, vascular, cardiac, and neuro systems.
- Quantity
- 202
- Codes and lots
- 00000869963YM9 00000145536HM9 00000869962YM1 00000919517YM3 00000919516YM5 00000813945YM3 00000897706YM8 00000813948YM7 00000000798YR9 00000869950YM6 00000813943YM8 00000813958YM6 00000000821YR9 00000837351YM6 00000869949YM8 00000000138YR8 00000837360YM7 00000965778YM4 00000952559YM3 00000000125YR5 00000919523YM1 00000000139YR6 00000000563YR7 00000801209YM8 00000919507YM4 00000869954YM8 00000965828YM7 00000837365YM6 00000801204YM9 00000869953YM0 00000963007YM0 00000837352YM4 00000000812YR8 00000000826YR8 00000000775YR7 00000813947YM9 00000000773YR2 00000919524YM9 00000000827YR6 00000000762YR5 00000000759YR1 00000000130YR5 00000000757YR5 00000869966YM2 00000919519YM9 00000813950YM3 00000000756YR7 00000837359YM9 00000965860YM0 00000000760YR9 00000897700YM1 00000000784YR9 00000000771YR6 00000813960YM2 00000000796YR3 00000000788YR0 00000869956YM3 00000000809YR4 00000144942HM0 00000869961YM3 00000837364YM9 00000000774YR0 00000919526YM4 00000813959YM4 00000952563YM5 00000000786YR4 00000897708YM4 00000000785YR6 00000897716YM7 00000000586YR6 00000837347YM4 00000000768YR2 00000000835YR9 00000000123YR0 00000869947YM2 00000801202YM3 00000801208YM0 00000801206YM4 00000000758YR3 00000000818YR5 00000965775YM0 00000000770YR8 00000000816YR9 00000000564YR5 00000837350YM8 00000000561YR1 00000965780YM0 00000919513YM2 00000813956YM0 00000000825YR0 00000952565YM0 00000000783YR1 00000897699YM5 00000837346YM6 00000869952YM2 00000000772YR4 00000897703YM5 00000919512YM4 00000919521YM5 00000952561YM9 00000919514YMO 00000952547YM8 00000000797YR1 00000813955YM2 00000000776YR5 00000837348YM2 00000813957YM8 00000000781YR5 00000919520YM7 00000919520YM7 00000897714YM2 00000000143YR8 00000801203YM1 00000801199YM1 00000000777YR3 00000000116YR4 00000919509YM0 00000801193YM4 00000184989MR2 00000000117YR2 00000000140YR4 00000869948YM0 00000000767YR4 00000897711YM8 00000000769YR0 00000000141YR2 00000000763YR3 00000897717YM5 00000000766YR6 00000000787YR2 00000869965YM4 00000000565YR2 00000919511YM6 00000813944YM6 00000000794YR8 00000837353YM2 00000000791YR4 00000000823YR5 00000000765YR8 00000000782YR3 00000000824YR3 00000000811YR0 00000919518YM1 00000000761YR7 00000000819YR3 00000965831YM1 00000000836YR7 00000965785YM9 00000965783YM4 00000897698YM7 00000000779YR9 00000952554YM4 00000000828YR4 00000000801YR1 00000000789YR8 00000000803YR7 00000965837YM8 00000919515YM7 00000000832YR6 00000952564YM3 00000952558YM5 00000897715YM9 00000952552YM8 00000000840YR9 00000000790YR6 00000965840YM2 00000000830YR0 00000000800YR3 00000000799YR7 00000919510YM8 00000000838YR3 00000000834YR2 00000952549YM4 00000965767YM7 00000952566YM8 00000000831YR8 00000965836YM0 00000000805YR2 00000000839YR1 00000965768YM5 00000965841YM0 00000897705YM0 00000965774YM3 00000000841YR7 00000952550YM2 00000952548YM6 00000000808YR6 00000000795YR5 00000952555YM1 00000000807YR8 00000965791YM7 00000965789YM1 00000000793YR0 00000000810YR2 00000000780YR7 00000161742HM2 00000000778YR1 00000000837YR5 00000965793YM3 00000000804YR5…
- Recall started
- Aug. 23, 2010
- Device type
- System, Nuclear Magnetic Resonance Imaging
- Root cause (FDA)
- Nonconforming Material/Component
- What the company told customers
- Consignees were sent on 8/23/10 a GE "Urgent Medical Device Correction" letter dated August 20, 2010. The letter was addressed to Hospital Administrators / Risk Mangers, Radiology Department Managers and Radiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction, and Contact Information. Customers were asked to discontinue use of their MR system and to contact their local service representative, if the lateral table adjustment crank handle on the table becomes loose.
- Recall number
- Z-0426-2011
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0425-2011, Z-0426-2011. The agency record governs; check it and the company before acting.