FDA Device recall Z-0142-2022
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
- FDA Device
- Class II
- terminated
- Published 2021-10-27
On 2021-10-27 the FDA classified a Class II recall of Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A by Canon Medical System Usa, citing 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 s….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0142-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-11 |
| Published | 2021-10-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Canon Medical System Usa |
| Distribution | US |
Product
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Reason
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.
Identifiers
| code_info | Affected serial numbers: 3DA1982001, 3DA2072002, 3DA2072003 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0142-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.