Recall Z-0142-2022— Canon Medical System, USA, INC.

Name: FDA recall Z-0142-2022
Creator: U.S. Food and Drug Administration
Published: 2020-11-11

Class II · Terminated

Class II FDA medical device recall by Canon Medical System, USA, INC., initiated 2020-11-11, terminated 2023-06-30. It names one FDA 510(k) clearance: K203314. 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..

Recalling firm: Canon Medical System, USA, INC.
Classification: Class II
Status: Terminated
Initiated: 2020-11-11
Terminated: 2023-06-30
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K203314 — Cartesion Prime (PCD-1000A/3) V10.8Canon Medical Systems Corporation·cleared 2021-04-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.