Canon Medical System, USA, INC. Recall 88691
Description: Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Canon Medical System, USA, INC. Recall 88691 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0142-2022 |
| Event ID | 88691 |
| Event Description | Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of NV, AR MN. |
| Quantity | 3 units |
| Recall 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. |
| Device Classification | 20211027 |
| Device Code Info | Affected serial numbers: 3DA1982001, 3DA2072002, 3DA2072003 |
| Center Classification Date | 20211019 |
| Recall Initiation Date | 20201111 |
| Recalling Firm | Canon Medical System, USA, INC. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Similar To |