Reported Mar 9, 2016 · Terminated
NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes of coil arrays and one interface box.…
NeoCoil, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NeoCoil, LLC · N27W23910 Paul Rd Ste A · Pewaukee, WI · 53072-6204
Is this the product you have?
- NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes of coil arrays and one interface box. 3.0T GEM Flex, Interface 16ch Fixed, P -Connector, NC032204, GEHC part number 5430008-5. 3.0T GEM Flex Coil16-L Array, NC040200, GEHC part number 5430008-2. 3.0T GEM Flex Coil 16-M Array, NC033000, GEHC part number 5430008-3. 3.0T GEM Flex Coil 16-S Array, NC034200, GEHC part number5430008-4. The 3.0T GEM Flex Coil (interface box and arrays) is used in conjunction with a 3.0T GE Magnetic Resonance Scanner
- Lot codes and dates
53 of 53 products
Products covered by this recall Model / number Barcodes Product as published 0000040-4-0228082427040146— 0000033-4-0232082427040146— 0000034-4-02190824270401460000040-4-0295 EM0258 0000033-4-0297 EM0258 0000034-4-0276 EM0258 0000040-4-0273082427060052— 0000033-4-0275082427060052— 0000034-4-02540824270600520000040-4-0375 KW1100MR02 0000033-4-0378 KW1100MR02 0000034-4-0341 KW1100MR02 0000040-4-0285082427100219— 0000033-4-0286082427100219— 0000034-4-02700824271002190000040-4-0449 M4035023 0000033-4-0452 M4035023 0000034-4-0391 M4035023 0000040-4-0290082427110051— 0000033-4-0291082427110051— 0000034-4-02730824271100510000040-4-0419 MRUA0459 0000033-4-0422 MRUA0459 0000034-4-0370 MRUA0459 0000040-4-0163082427120110— 0000033-4-0165082427120110— 0000034-4-01590824271201100000040-4-0181 QA1042MR01 0000033-4-0182 QA1042MR01 0000034-4-0176 QA1042MR01 0000040-4-0246082427120116— 0000033-4-0249082427120116— 0000034-4-02310824271201160000040-4-0460 ZC0002 0000033-4-0462 ZC0002 0000034-4-0399 ZC0002 0000040-4-0269082427120124— 0000033-4-0273082427120124— - Amount recalled
- 2121
Where it was sold
- Nationwide
Why it was recalled
Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns.
This product could cause temporary or reversible health problems — stop using it.
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