Lower riskMedical device recall · FDA · Published November 11, 2020
Canon PET-CT Scanner PCD-1000A: Software Issue May Cause Rescanning
Canon Medical recalls PET-CT scanner model PCD-1000A due to software causing potential rescanning and contrast reinjection. Affected units have specific serial numbers.
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.
Take action
Contact the company
📍Recalling firmCanon Medical System, USA, INC.2441 Michelle Dr · Tustin, CA 92780-7047
“Canon PET-CT Scanner PCD-1000A: Software Issue May Cause Rescanning.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63935-canon-pet-ct-scanner-pcd-1000a-software-issue-may-cause. Based on FDA recall #Z-0142-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0142-2022%22&limit=1).
The FDA announced on November 11, 2020, that Canon Medical System, USA, INC. is recalling the Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A due to a software problem that could prevent scans from proceeding. The agency said this defect may result in rescanning and reinjection of contrast medium.
How to tell if you have it
Brand: Canon Medical
Product: Canon PET-CT SCANNER, Cartesion Prime
Model: PCD-1000A
Affected serial numbers: 3DA1982001, 3DA2072002, 3DA2072003
Units affected: 3
The hazard
According to the FDA, 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.
Context
GovInfoNow's records show Canon Medical System, USA, INC. has 27 other recalls on record since April 18, 2018. Other recent recalls of similar products include Canon Alphenix INFX-8000C/B5 Recall (August 26, 2026), Canon Alphenix X-ray Systems Recall (August 4, 2026), and Canon Alphenix INFX-8000C X-ray System Recall (December 19, 2025). Other recent recalls of similar products include Philips Brilliance CT Scanners (August 7, 2026), Philips Achieva 3.0T MRI Recalled (August 21, 2026), and Philips Spectral CT 7500 Scanner (August 18, 2026).
How to tell if you have this one
Check if your scanner has the model name 'PCD-1000A' and the specific serial numbers: 3DA1982001, 3DA2072002, or 3DA2072003.
Brand
Canon Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Number
Verify your scanner's serial number to see if it matches the affected numbers: 3DA1982001, 3DA2072002, or 3DA2072003.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of NV, AR MN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arkansas, Minnesota, Nevada.
Recall timeline
FDA terminated this recall 2.6 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0142-2022 (November 11, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0142-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.