Canon PET-CT SCANNER — Class II medical device recall Z-0142-2022
Terminated recall by Canon Medical System, USA, INC., reported 2021-10-27, distributed nationwide. A software problem has been identified which could result in the diagnostic imaging system not proceeding to t
| Recall number | Z-0142-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Canon Medical System, USA, INC., Tustin, CA, United States |
| Recall initiated | 2020-11-11 |
| Classified | 2021-10-19 |
| Reported by FDA | 2021-10-27 |
| Terminated | 2023-06-30 |
| Distributed | Nationwide (US) |
| Quantity | 3 units |
| Reason classes | software |
| Serial numbers | 3DA1982001, 3DA2072002, 3DA2072003 |
| Model numbers | PCD-1000A |
Product
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Reason for recall
A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the diagnostic imaging system failing resulting in rescanning and reinjection of contrast medium.
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-0142-2022. 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.