Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Reported: October 27, 2021 Initiated: November 11, 2020 #Z-0142-2022
Product Description
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.
Details
- Recalling Firm
- Canon Medical System, USA, INC.
- Units Affected
- 3 units
- Distribution
- US Nationwide distribution in the states of NV, AR MN.
- Location
- Tustin, CA
Frequently Asked Questions
What product was recalled? ▼
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A. Recalled by Canon Medical System, USA, INC.. Units affected: 3 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 27, 2021. Severity: Moderate. Recall number: Z-0142-2022.
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