FDA Device recall Z-1928-2016

Optima 1.5T MR430s 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 Optima 1.5T MR430s 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-1928-2016
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

Optima 1.5T MR430s 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	0001272012-001 615VEMR 0003062012-008 605328SMR15 0012102012-001 SMRDEMO01 0005162012-003 801243MR2 SM05132013-001… 0001272012-001 615VEMR 0003062012-008 605328SMR15 0012102012-001 SMRDEMO01 0005162012-003 801243MR2 SM05132013-001 970879MR430 SM10172011-004 509482MR3 SM06142013-001 641428ONI SM10302012-006 ARIA430S SM06272013-006 207OA430MR SM11262012-007 USOTCSMR SM07082013-012 719766SMR 0SM5312013-001 760725MR1 SM08152013-002 703805ONIMR4 SM11252013-001 310665MR 0000SM09202013 208557MR2 SM05212013-004 VAD430 SM11132012-002 856581MR430 SM12172012-001 303577MR2 0001212012-001 786308MR1 0012222011-001 973586MR 0006012011-001 SINAI601 0007132011-001 516482MR430 0012042011-001 MKMG430S 0 02162012-001 805679ONI 0012142011-001 215DOY430S 0006112012-004 360786ONIMR 0003062012-007 212288ONI 0010272011-009 513636NICMR 0003282012-001 518453MR2 0002112012-001 803434ONI Missing_SN_GON4194272 402EXTMR SM03132014-002 H430SMR SM05142014-006 520VAONIMR SM07182014-009 352376ONI1 SM11062012-001 MRSM11062012001 0002022012-001 0910272081 0004212012-001 514697ONI SM01232014-003 SM01

code_info

0001272012-001 615VEMR 0003062012-008 605328SMR15 0012102012-001 SMRDEMO01 0005162012-003 801243MR2 SM05132013-001…

0001272012-001 615VEMR 0003062012-008 605328SMR15 0012102012-001 SMRDEMO01 0005162012-003 801243MR2 SM05132013-001 970879MR430 SM10172011-004 509482MR3 SM06142013-001 641428ONI SM10302012-006 ARIA430S SM06272013-006 207OA430MR SM11262012-007 USOTCSMR SM07082013-012 719766SMR 0SM5312013-001 760725MR1 SM08152013-002 703805ONIMR4 SM11252013-001 310665MR 0000SM09202013 208557MR2 SM05212013-004 VAD430 SM11132012-002 856581MR430 SM12172012-001 303577MR2 0001212012-001 786308MR1 0012222011-001 973586MR 0006012011-001 SINAI601 0007132011-001 516482MR430 0012042011-001 MKMG430S 0 02162012-001 805679ONI 0012142011-001 215DOY430S 0006112012-004 360786ONIMR 0003062012-007 212288ONI 0010272011-009 513636NICMR 0003282012-001 518453MR2 0002112012-001 803434ONI Missing_SN_GON4194272 402EXTMR SM03132014-002 H430SMR SM05142014-006 520VAONIMR SM07182014-009 352376ONI1 SM11062012-001 MRSM11062012001 0002022012-001 0910272081 0004212012-001 514697ONI SM01232014-003 SM01

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-1928-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.