MSK 1.5T Extreme MR Scanner, a diagnostic imaging device
FDA Device Recall #Z-1927-2016 — Class II — May 9, 2016
Recall Summary
| Recall Number | Z-1927-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 9, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Healthcare, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 97 |
Product Description
MSK 1.5T Extreme MR Scanner, a diagnostic imaging device
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.
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
Lot / 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
Other Recalls from GE Healthcare, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1566-2022 | Class II | (1) GE Centricity Universal Viewer 6.0, Model 2... | Jul 15, 2022 |
| Z-1430-2022 | Class II | SIGNA Premier magnetic resonance scanner, model... | Jun 24, 2022 |
| Z-1466-2022 | Class II | Centricity PACS Software Version 7.0 SP0.0.4.7 | Jun 14, 2022 |
| Z-1333-2022 | Class II | GE Centricity Universal Viewer Zero Footprint. ... | Jun 8, 2022 |
| Z-1511-2022 | Class II | Service manuals for the CT, PET, or NM table as... | Jun 2, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.