Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0142-2022 — Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A

U.S. FDA — Device Enforcement · United States · 2020-11-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0142-2022
Date of alert
2020-11-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Canon Medical System, USA, INC.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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