GE Healthcare LLC Announces Recall of SIGNA Premier Systems

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

GE Healthcare LLC is voluntarily recalling 41 SIGNA Premier systems due to potential risks from ferrous fittings that could cause injury during servicing.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 14, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

GE Healthcare LLC is recalling SIGNA Premier systems because they may have been manufactured or serviced with ferrous fittings instead of non-ferrous ones. This could result in the fittings being attracted by the magnetic field if the system is accessed during service, potentially leading to personnel injury.

Which Products Are Affected

The affected products are SIGNA Premier systems, with a total quantity of 41 units. The systems include the following codes: 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 was nationwide in the United States, specifically in the states of CA, MA, NJ, NY, OH, SD, TX, VA, and PR, as well as worldwide in countries including Sweden, Switzerland, United Kingdom, Vietnam, China, Norway, Portugal, Spain, France, Germany, Greece, Korea, Republic of. The recall number is Z-1767-2026.

What You Should Do

Consumers should contact the recalling firm, GE Healthcare LLC, for information on this recall, as it was initiated voluntarily by the firm.

Why This Matters

This recall affects medical devices used for diagnostic imaging and highlights potential safety risks in healthcare equipment manufacturing, which could impact personnel safety during servicing.

Source

FDA recall database: https://www.fda.gov/ (Attribution: FDA, Recall Number Z-1767-2026)

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
GE Healthcare LLC is voluntarily recalling 41 SIGNA Premier systems due to potential risks from ferrous fittings that could cause injury during servicing.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.