Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
- Company
- Canon Medical System, Usa, Inc.
- Recall Initiated
- November 11, 2020
- Terminated
- June 30, 2023
- Recall Number
- Z-0142-2022
- Quantity
- 3 units
- Firm Location
- Tustin, CA
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.
Distribution
US Nationwide distribution in the states of NV, AR MN.
Lot / Code Info
Affected serial numbers: 3DA1982001, 3DA2072002, 3DA2072003
Root Cause
Software design
Action Taken
On November 11, 2020, Canon Medical Systems visited affected consignees and updated affected software. After completion of the software update, the consignee was provided a "Recall field Modification Instruction" document concerning the correction.
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