FDA Device recall Z-1927-2016

MSK 1.5T Extreme MR Scanner, a diagnostic imaging device

FDA Device
Class II
terminated
Published 2016-06-15

On 2016-06-15 the FDA classified a Class II recall of MSK 1.5T Extreme MR Scanner, a diagnostic imaging device by Ge Healthcare, citing the gas venting may not occur properly. A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1927-2016
Classification	Class II
Status	terminated
Initiated	2016-05-09
Published	2016-06-15
Last updated	2026-09-13 11:54 UTC
Company	Ge Healthcare
Distribution	AL, AZ, CA, CO, FL, IA, ID, IL, ME, NC, NE, NH, NJ, NV, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI

Product

MSK 1.5T Extreme MR Scanner, a diagnostic imaging device

Reason

The gas venting may not occur properly. A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients.

Identifiers

code_info	Mfg Lot or Serial # System ID 0001072011-001 708216MR3 0001082010-001 AIC202 0001272010-001 RADNETMR1656 0002032011… Mfg Lot or Serial # System ID 0001072011-001 708216MR3 0001082010-001 AIC202 0001272010-001 RADNETMR1656 0002032011-001 407333EXTMR 0003072010-001 702254LVRMR 0003242009-001 JCI178 0004012010-001 201487ONI 0005152009-001 ZPR2185 0005262010-001 CALPAC003 0006012008-001 MHMH162 0006082010-001 SPRUCEEXT 0006182010-001 205930MR3 0007142009-001 POA187 0009142010-001 6150 0009172009-001 RADNETMR1641 0010182010-001 305CMI2 0011292010-001 513636EXTMR 0012052010-001 713791BONIMR 0012162008-001 HCH170 0012182008-001 916734EXMR 0007152011-001 MREQUINE3 SM12062013-002 718518MR430S 0008152010-001 0910272074 0008142012-001 AP4502MR01 0004082010-001 MR04082010 0005072010-001 MR05072010 0007082010-001 MR07082010 0007092010-001 MR07092010 0011242009-001 MR11242009 0012142009-001 MR12142009 0012152009-001 MR12152009 0003292011-001 EG1252MR02 0004192011-001 EG1524MR01 SM02042013-001 607849MR01 SM04292013-001 PC0127MR04 SM05062013-001 533398MR01 SM06092014-002 419793MR

code_info

Mfg Lot or Serial # System ID 0001072011-001 708216MR3 0001082010-001 AIC202 0001272010-001 RADNETMR1656 0002032011…

Mfg Lot or Serial # System ID 0001072011-001 708216MR3 0001082010-001 AIC202 0001272010-001 RADNETMR1656 0002032011-001 407333EXTMR 0003072010-001 702254LVRMR 0003242009-001 JCI178 0004012010-001 201487ONI 0005152009-001 ZPR2185 0005262010-001 CALPAC003 0006012008-001 MHMH162 0006082010-001 SPRUCEEXT 0006182010-001 205930MR3 0007142009-001 POA187 0009142010-001 6150 0009172009-001 RADNETMR1641 0010182010-001 305CMI2 0011292010-001 513636EXTMR 0012052010-001 713791BONIMR 0012162008-001 HCH170 0012182008-001 916734EXMR 0007152011-001 MREQUINE3 SM12062013-002 718518MR430S 0008152010-001 0910272074 0008142012-001 AP4502MR01 0004082010-001 MR04082010 0005072010-001 MR05072010 0007082010-001 MR07082010 0007092010-001 MR07092010 0011242009-001 MR11242009 0012142009-001 MR12142009 0012152009-001 MR12152009 0003292011-001 EG1252MR02 0004192011-001 EG1524MR01 SM02042013-001 607849MR01 SM04292013-001 PC0127MR04 SM05062013-001 533398MR01 SM06092014-002 419793MR

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1927-2016%22

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