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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98579

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 27, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
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

1 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 1

SIGNA Premier systems

Z-1767-2026
Recall number
Z-1767-2026
Initiated
February 27, 2026
Classification
Class II
Status
Ongoing
Recalling firm
GE Healthcare LLC
Quantity
41

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.

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

Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.

Code information

UDI-DI/GTIN: 00840682135269, 00195278010797. System ID: 415353UMR2, 415723SHMR19, 413253MR3T, 908725MR, 609652MR3T, M48823, 7168453T, 513584MR5, 513636EASTMR, 513636T1MR, 605333MRPRM, 832522CRMR1, 703858PRE2, 804675VA3T, 082427110162, 082427220143, 082427020147, 082427200242, 082427160461, 082427250139, 082427140382, M4216469, 353745MR01, GON5655515, KRMR56474971, KRMR56203791, KRMR55433661, KRMR56344161, KRMR55774051, KRMR55914661, NOMRI26833321, 15974045, GON1882380, ESMRI27056983, ESMRI26960129, A203MR06, 690120MR01, 11524261, VNMRI26792525, VNMRI26592248, VNMRI26809677

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, MA, NJ, NY, OH, SD, TX, VA, PR and the countries of Sweden, Switzerland, United Kingdom, Vietnam, China, Norway, Portugal, Spain, France, Germany, Greece, Korea, Republic of

Field note

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