What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

Is Optima MR360, NMRI system recalled?

Yes. FDA lists a Class II recall by GE Healthcare (China) Co., Ltd. for Optima MR360, NMRI system, reported 20250305, with status "Ongoing." FDA recall number: Z-1241-2025.

FDA Class II Recall: Optima MR360, NMRI system by GE Healthcare (China) Co., Ltd.

Key facts

Recalling firm	GE Healthcare (China) Co., Ltd.
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	Optima MR360, NMRI system
Classification	Class II
Recall number	Z-1241-2025
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.

Key takeaway: FDA classified a recall by GE Healthcare (China) Co., Ltd. as Class II, reported 20250305. The affected product is Optima MR360, NMRI system (recall number Z-1241-2025). Reason for recall: For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.. Status: Ongoing.

What this classification means

A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class II, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of Optima MR360, NMRI system should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from GE Healthcare (China) Co., Ltd.. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from GE Healthcare (China) Co., Ltd. should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to GE Healthcare (China) Co., Ltd. directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

GE Healthcare (China) Co., Ltd.’s FDA history

Argus HQ has recorded 24 total FDA actions tied to GE Healthcare (China) Co., Ltd.: 0 warning letters, 24 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What is the FDA recall number for this event?: FDA recall number Z-1241-2025.
What is the current status of this recall?: Status as recorded by FDA: Ongoing.
Where can I verify this recall directly with FDA?: The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.
Is Optima MR360, NMRI system recalled?: Yes. FDA lists a Class II recall by GE Healthcare (China) Co., Ltd. for Optima MR360, NMRI system, reported 20250305, with status "Ongoing." FDA recall number: Z-1241-2025.

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Full FDA history for GE Healthcare (China) Co., Ltd.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2025). FDA Class II Recall: Optima MR360, NMRI system by GE Healthcare (China) Co., Ltd. — Recall Details. Digital Empire LLC. Retrieved from https://argushq.ai/recall/ge-healthcare-china-z-1241-2025-2025-03-05

MLA

"FDA Class II Recall: Optima MR360, NMRI system by GE Healthcare (China) Co., Ltd. — Recall Details." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/recall/ge-healthcare-china-z-1241-2025-2025-03-05.

Chicago

Argus HQ Research. "FDA Class II Recall: Optima MR360, NMRI system by GE Healthcare (China) Co., Ltd. — Recall Details." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/recall/ge-healthcare-china-z-1241-2025-2025-03-05.

BibTeX

@misc{argushq_argushq_ai_recall_ge_healthcare_china_z_1241_2025_2025_03_05_2025,
  title = {FDA Class II Recall: Optima MR360, NMRI system by GE Healthcare (China) Co., Ltd. — Recall Details},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/ge-healthcare-china-z-1241-2025-2025-03-05},
  note = {Accessed: July 17, 2026}
}

Source: FDA.gov — Recalls ↗