# FDA recall Z-0142-2022

> **Canon Medical System, USA, INC.** · Class II · device recall initiated 2020-11-11.

## Product

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.

## Distribution

US Nationwide distribution in the states of NV, AR MN.

## Key facts

- **Recall number:** Z-0142-2022
- **Recalling firm:** Canon Medical System, USA, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-11
- **Report date:** 2021-10-27
- **Termination date:** 2023-06-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tustin, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0142-2022

## Citation

> AI Analytics. FDA recall Z-0142-2022. Retrieved 2026-08-01 from https://api.ai-analytics.org/recall/Z-0142-2022. Source: US FDA. Licensed CC0.

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