Exact FDA event identifier

Event 74215

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: May 09, 2016
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: GE Healthcare, LLC

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

MSK 1.5T Extreme MR Scanner, a diagnostic imaging device

Z-1927-2016

Recall number: Z-1927-2016
Initiated: May 09, 2016
Classification: Class II
Status: Terminated
Recalling firm: GE Healthcare, LLC
Quantity: 97

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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 419793MR01 SM06182013-001 PC4318MR03 SM07182014-005 115530MR01 SM08152013-001 123701MR01 SM09132012-003 PC9982MR01 SM12122013-001 123955MR01 0001022012-001 PC0362MR03 0001152012-001 414456MR01 0001182010-001 PC7485MR01 0003012010-001 PY4178MR02 0003142012-007 761131MR01 0005132011-001 PC3756MR01 0006042009-001 PC5454MR01 0006062009-001 HC9457MR01 0006142012-001 805467MR01 0006212012-001 CC3829MR01 0006282012-010 PC0573MR03 0006302011-001 PC0075MR04 0007172012-001 654076MR01 0007232012-001 PC4712MR01 0007252012-001 PC1820MR01 0007272010-001 HC4201MR01 0008022011-001 PC3814MR03 0008142011-001 440719MR01 0009072009-001 PC8854MR01 0009092011-001 PC6543MR01 0009132010-001 PC1345MR01 0009172011-001 743862MR01 0010082010-001 TP0008MR03 0010082011-001 PKOB02MR05 0010172011-002 125995MR02 0011162010-001 126538MR02 0011202011-001 PC4529MR02 0012102011-001 788048MR01 SM02142014-001 123959MR01 SM07142014-002 PC4616MR01 0001182011-001 H10634MR11 0009062011-001 A5992702 0003302011-001 0834270017 0002182011-001 OSH02U875 0009222010-001 HRL03U800 0010142009-001 LDN01U735 0010312010-001 NO1009MR01 0008132009-001 DPN26323 0012222010-001 FPG09900 0007222011-001 A022MR01 SM07182014-016 475350MR01 SM07252013-003 266150MR04 0002112010-001 259200MR01 0003202012-004 121497MR01 0005172011-001 685544MR01 0005182012-001 107010MR02 0006222011-001 350010MR03 0007112012-002 265050MR02 0010222010-001 849010MR03 SM07182014-015 750100MR03 0008122009-001 UK1120MR01 0010082009-001 AE1141MR01 0002242010-001 00506MRS02 0006092011-001 00440MRS06 0009222009-001 00516MRS01

Distribution pattern

US: AL, AZ, CA, CO, FL, ID, IL, IA,ME, NE, NV,NH, NJ, NY, NC, OH, PA, SC, SD, TN, TX, UT,VA, WA, WI. OUS: Argentina Australia Austria Brazil Canada Chile Colombia Denmark Egypt Finland France Germany Greece Hong Kong Iceland Italy Japan Korea (Republic of) Kuwait Malaysia Netherlands Norway Peru Poland Portugal Russia Singapore South Africa Spain Sweden Switzerland Ukraine United Arab Emirates United Kingdom

device · product 2 of 2

Optima 1.5T MR430s MR Scanner, a diagnostic imaging device

Z-1928-2016

Recall number: Z-1928-2016
Initiated: May 09, 2016
Classification: Class II
Status: Terminated
Recalling firm: GE Healthcare, LLC
Quantity: 101

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Code information

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 SM01232014-003 SM05192014-003 MRSM05192014003 0005252012-002 MRMEDSMR3 SM02252014-003 082427010079 SM03292014-007 082427020055 SM05272014-007 082427020060 SM09202013-017 082427040145 0SM0225013-004 082427030080 SM06202013-002 MRSM06182013002 SM01202014-014 DK1000MR04 SM10242013-002 DK1075MR01 0000DK1030MR03 DK1030MR03 0012132011-001 DK1068MR01 0001192012-001 FI1378MR01 0011052011-002 FI1006MR02 SM01102014-001 M24070304 SM01152013-001 L1650217 SM03052014-004 M176430610 SM04152014-001 M5817305 SM04292014-002 M2862820 SM07182014-014 M172471308 SM08152013-003 M4215583 SM12192013-003 M219000205 SM02042014-003 D4185525 SM07182014-008 0828270040 0002042012-001 IS1019MR01 SM10122012-003 A5177233 SM12102012-003 A287971801 0007172011-001 A127292410 0009242011-001 A5725513 SM02132014-001 OM0005 SM03202014-001 OM0004 SM11122013-007 OM0003 SM12202013-001 OM0100 0005102012-004 OM0001 0008022012-003 OM0002 0007302012-008 0850270400 SM07182014-012 KW1019MR04 SM07182014-013 KW1001MR05 0005152012-004 DRD0120 SM07142014-003 GRN0121 SM01072013-005 SM01072013-005 0005032012-004 PL2783MR01 SM04212014-003 PPR74710 0008032012-001 RU1086MR04 SM03062013-001 0847270030 SM07152013-008 0847270032 0010172011-001 0847270028 SM04072014-012 ZA2630MR01 SM08152012-001 ZA2458MR01 SM03142013-002 NPV15969 SM10162013-004 CEZ01534 0003092012-001 MPX19500 0004172012-001 DPN26330 0007112011-001 UP925714 0010092011-001 DPN89106 0010242011-007 UPW01900 0011052011-001 NPV22527 0012262011-001 MPX27417 0008102011-001 N006MR02 SM07182014-007 C001MR02 SM11212013-001 AE1444MR01 0001232012-001 10476MRS01 0008152010-001 0910272078