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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80287

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

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Event summary

Timeline bucket
March 30, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
GE Medical Systems, 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

MR Surgical Suite Option Product The MR Surgical Option when integrated with the GE Signa¿ 3.0T or 1.5T magnetic resonance scanner (previously cleared K041476) can be used to produce head and whole body magnetic resonance images that are high resolution high signal-to-noise ratio, with short scan times. The Signa¿ Excite MR system with Surgical Option is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa Excite system with Surgical Option reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The GE Signa Excite system with Surgical Option can provide MR images at various stages of a surgical procedure, and provides the capability to transfer a patient to the MR system table directly from a surgical table, or patient transport system. Images can be obtained using the MR scanner body coil, or local surface coils, and tile surface coils used with the integrated system may / can accommodate sterile draping for surgical procedures.

Z-2527-2018
Recall number
Z-2527-2018
Initiated
March 30, 2018
Classification
Class II
Status
Terminated
Recalling firm
GE Medical Systems, LLC
Quantity
54 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential safety issue with the table transfer release of the MR Surgical Suite System which may cause an unexpected loss of function of the patient transfer mechanism that allows the patient to be moved from the GE MR Surgical Table to the Maquet Magnus Surgical Table.

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

There is a potential safety issue with the table transfer release of the MR Surgical Suite System which may cause an unexpected loss of function of the patient transfer mechanism that allows the patient to be moved from the GE MR Surgical Table to the Maquet Magnus Surgical Table.

Code information

Model Numbers M8074SS, M8053SS, M0074SS, M0001SS, 5265300-7, 5265300-8. Serial Number (System ID Number): 00000000000002 (602406IMR), 4295404 (4295404MR11), N/A (415UCBHMR3), N/A (720848MR4), 00000304124MR1 (904202MR8), N/A (309655IMRI), 4425007 (913588NMRW), 00000000UA0117 (616267IMRI), 00000000000003 (507284NMRV), 4311497 (MR229054), 4510086 (212636SIGNA3T), 00000000UA0116 (330344MR750W), UA0326 (614293MR9), N/A (614RMHTMR1), 4371613 (412692MR750W), N/A (214820ITABLE), 4250114 (409772MR6), 4550641 (4550641MR11), 4482037 (757388750WMR), 00000012228M63 (608263MR4IOR), 4356151 (414805IMR1), 00000299229MR5 (AH5824MR01), 00000012051M69 (AH5824SS01), 00000021158M61 (MRHM0885), 00000014131M67 (MRHM0323), 00000018480M64 (MR307144MR6), 4565719 (082427110075), 00000013254M68 (082445160014), 000000PTST0008 (082427040101), 000000PTST0007 (082427050024), 4596631 (082427310113), 4409769 (082427140133), 000000PTST0003 (CS1020MR01), DUMFMI60885001 (CS1006MR03), 00001309FMM07L (T4185506), 00000021695M62 (M4194477), 00000021695M62 (X41944020), 00000305145MR5 (UC2547MR01), 4320023 (083027822002316), 4508956 (A5381507), 00000010003M62 (EM0293), 00001219FMM0H1 (EM0105), 00000017217M61 (EM0105), 000000PTST0010 (YM3833), 00000000000004 (YM1733), 2937140 (0850270414), 4548529 (KW1008MR08), 000000PTST0006 (ZA2169MR01), 00001251FMM044 (34368MRS01), 4344097 (34418MRS01), 4605737 (N/A), 000000PTST0005 (10590MRS01), DUMFMI60885002 (10590MRS02), 4569734 (00132MRS01)

Distribution pattern

US Nationwide distribution to AZ, CA, CO, FL, IL, KS, MI, MN, NY, OH, PA, TX, UT, VA, WI. Worldwide distribution to Austria, Brazil, China, Czech Republic, France, Germany, India, Italy, Japan, Korea, Kuwait, South Africa, Turkey, Turkey, United Arab Emirates, United Kingdom.