Z-0142-2022Class II

Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A

Name: Z-0142-2022 Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Creator: Canon Medical System, USA, INC.
Published: 2020-11-11
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2020-11-11 / Terminated / root cause: software

FDA source

Canon Medical System, USA, INC. began a recall of Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A on 2020-11-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0142-2022
Classification: Class II
Status: Terminated
Initiated: 2020-11-11
Posted: 2021-10-19
Terminated: 2023-06-30
Recalling firm: Canon Medical Systems USA, Inc.
Product: Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Product code: KPS System, Tomography, Computed, Emission
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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 3 units
Distribution: US Nationwide distribution in the states of NV, AR MN.
Product codes and lots: Affected serial numbers: 3DA1982001, 3DA2072002, 3DA2072003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0142-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0142-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-27	2021-10-19

Product code KPS

K203314Class IICartesion Prime (PCD-1000A/3) V10.8Canon Medical Systems Corporation / cleared 2021-04-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)