Tomographic Imager Combining Emission Computed Tomography With… — Class II medical device recall Z-0131-2021
Terminated recall by GE Healthcare, LLC, reported 2020-10-28, distributed nationwide. Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
| Recall number | Z-0131-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2020-09-08 |
| Classified | 2020-10-20 |
| Reported by FDA | 2020-10-28 |
| Terminated | 2021-04-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CN, HU, IN, KR, RU, TW |
| Model numbers | 5726207-8, 5741000-28 |
Product
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.
Reason for recall
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0131-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.