Not Applicable 5494440Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

9 FDA recall records name this device's identifier.

5 other recalls cover devices cleared under the same FDA submission (K142098); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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 · FDA record ↗

2. 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 · FDA record ↗

3. 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 · FDA record ↗

4. 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 · FDA record ↗

5. 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 · FDA record ↗

6. 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 · FDA record ↗

7. 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 · FDA record ↗

8. 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 · FDA record ↗

9. 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 · FDA record ↗

Recalls under the same FDA submission

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

• Z-2309-2025 · Jun 20, 2025 · Open, Classified
  GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance
• 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-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