Z-0858-2022 Class II Ongoing
FDA device recall Z-0858-2022 was initiated by GE Healthcare, LLC on Feb 18, 2022 and is designated Class II. Reason for recall: There is potential for the images to be flipped left to right. The recall status is ongoing. Affected quantity: 76 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 13, 2022
- Initiation Date
- Feb 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 76 units
Product Description
1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System
Reason for Recall
There is potential for the images to be flipped left to right.
Distribution Pattern
Worldwide Distribution. US nationwide, Argentina, Australia, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, China, Denmark, Ecuador, Ethiopia, France, Germany, Greece, Hong Kong, India, Iran, Ireland, Italy, Japan, Korea, Kuwait, Lebanon, Mexico, Netherlands, New Zealand, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
Code Information
System IDs: 928223MR3T, 360397MR2, 602406IMR, 480323MR1, 928SMIMR, 3825, 559325CIIMR1, 805988MR2, 6617263TMR, 650306SMR3T, 4036, 3600, 3266, 818RIMR3T, 4267, 352333MR3T, 407SOMR3T, 941PCMR, 386HPOMR, ALLIANCESIG463, 337261MR1, 601288MR3T, 662841MR4, 336713WFUMR, 609383MR, 201487MR, 805998MR1, 805998CR1, 702369SM3TLV, 405634S3T, 814234MR, 6053883T, 731425MR2, 901425MROP1, 806212MR3T, 409892SMR2, 972566MR3, 972378NSC3TMR1, 801377MR2, 910277003, 2577595, 082427090088, 082427210045, 082427270017, 082427160041, 082427040047, 082427040052, 082427040074, 082427210039, 082427090090, 082427310027, 082427100093, 082427140039, 082427030039, 082427100099, 082427100084, 082427070050, 082427070034, 082427310019, 082427100089, IR1503MR01, A5125121, A5806911, YM3034, 850270175, 850270176, 850270199, 850270361, 850270205, KW1004MR03, RF0754MR01, GEE34040, 0853270071, 0853270072, 34208MRS01, 34006MRS03
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0858-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026