NA SIGNA PET MR (UDI 00840682105378)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840682105378), received between Apr 15, 2026 and Apr 15, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

11 FDA recall records name this device's identifier, 2 still open.

6 other recalls cover devices cleared under the same FDA submission (K142098, K163619); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jun 20, 2025Open, Classified

   GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

   Z-2309-2025 · Root cause: Equipment maintenance · Recall details · FDA record ↗

2. May 23, 2025Open, Classified

   GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.

   Z-2133-2025 · Root cause: Device Design · Recall details · FDA record ↗

3. May 11, 2017Terminated

   Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

   Z-3029-2017 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗

4. May 11, 2017Terminated

   Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

   Z-3021-2017 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗

5. May 11, 2017Terminated

   Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

   Z-3023-2017 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗

6. May 11, 2017Terminated

   Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

   Z-3025-2017 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗

7. May 11, 2017Terminated

   Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

   Z-3028-2017 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗

8. May 11, 2017Terminated

   Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

   Z-3027-2017 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗

9. May 11, 2017Terminated

   Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

   Z-3024-2017 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗

10. May 11, 2017Terminated

    Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

    Z-3022-2017 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗

11. May 11, 2017Terminated

    Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

    Z-3026-2017 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Use of Device Problem; Insufficient Device Problem Information

  AFTER COMPLETION OF AN EXAM, A TECHNOLOGIST TRIPPED OVER TUBING FROM THE PATIENT ALERT BALL THAT HAD EXTENDED ONTO THE SCAN ROOM FLOOR WHILE THE PATIENT WAS REMOVED FROM THE BORE OF THE SCANNER. THE TECHNOLOGIST FELL, LANDING ON THE RIGHT KNEE, STRIKING THE NOSE, AND INJURING THE LEFT SHOULDER WHILE ATTEMPTING TO BRACE THE FALL. THE TECHNOLOGIST SOUGHT MEDICAL EVALUATION AT AN URGENT CARE FACILITY THE FOLLOWING DAY AND WAS DIAGNOSED WITH A LEFT CHEST CONTUSION AND LEFT SHOULDER STRAIN, WITH SUBSEQUENT INITIATION OF PHYSICAL THERAPY. NO PATIENT INJURY OCCURRED.

  Patient problems: Limb Pain

  MAUDE report 24884715 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142098, K163619. One submission often covers many models, so check the product and lot details in each record.

• Z-0520-2025 · Oct 28, 2024 · Open, Classified
  Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR,
• Z-2466-2024 · Jun 14, 2024 · Open, Classified
  SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emission computed tomography with nuclear magnetic resonance
• Z-0595-2022 · Dec 23, 2021 · Open, Classified
  GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomographic imager combining emission computed tomography with nuclear magnetic resonanc
• Z-2057-2021 · Jun 4, 2021 · Open, Classified
  SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
• Z-0131-2021 · Sep 8, 2020 · Terminated
  Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET
• Z-0260-2016 · Aug 31, 2015 · Terminated
  GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners tha