Lower risk Medical device recall · FDA · Published September 17, 2024

Canon Cartesion Prime PET-CT Recall: PET Reconstruction May Hang During Scans

Canon Medical recalls specific models of Cartesion Prime PET-CT scanners due to potential PET reconstruction hangs during scans, requiring repeat exams. Affected units include PCD-1000A/3D.004 and PCD-1000A/3D models with serial numbers starting with 3DA20.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0284-2025Medical device Canon Medical ›

Lower-risk recall

When PET-CT system is executing reconstruction, if PET acquisition for another patient is performed (or PET reconstruction for another patient is performed from raw data processing), PET reconstruction control processing may hang up and PET reconstruction may stop as a result, which may necessitate repeat PET/CT examinations.

Take action

Contact the company

Recalling firmCanon Medical System, USA, INC.2441 Michelle Dr · Tustin, CA 92780-7047

✎ GovInfoNow plain-language explainer

Canon Medical is recalling certain Cartesion Prime PET-CT scanners that may cause PET reconstruction to hang during scans, potentially requiring repeat exams. This issue affects patients receiving imaging tests and could lead to longer wait times and additional costs. Read more at govinfonow.com/recall/54017-canon-cartesion-prime-pet-ct-recall-pet-reconstruction-may-hang.

Source Summary by GovInfoNow · govinfonow.com/recall/54017-canon-cartesion-prime-pet-ct-recall-pet-reconstruction-may-hang · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0284-2025

Cite this page

“Canon Cartesion Prime PET-CT Recall: PET Reconstruction May Hang During Scans.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54017-canon-cartesion-prime-pet-ct-recall-pet-reconstruction-may-hang. Based on FDA recall #Z-0284-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0284-2025%22&limit=1).

The FDA announced on Sept. 17, 2024, that Canon Medical System USA Inc. is voluntarily recalling its Cartesion Prime Digital PET-CT systems due to a hazard that may necessitate repeat examinations. The recall affects 27 units distributed across multiple U.S. states.

How to tell if you have it

Brand: Canon Medical
Product: Cartesion Prime, Digital PET-CT
Model: PCD-1000A/3D.004, PCD-1000A/3D
Software: V10.8 SP0013, V10.15 SP0006
Serial Numbers: 3DA1982001, 3DA2072002, 3DA2072003, 3DA20X2004, 3DA20Y2005, 3DA2112006, 3DA2132007, 3DA2162008, 3DA2192009, 3DA2242010, 3DA2252011, 3DA2262012, 3DA2272013, 3DA2272014, 3DA2282015, 3DA2292016, 3DA22Y2017, 3DA22Z2018, 3DA2322019, 3DA2322020, 3DA2332021, 3DA2332022, 3DA2342023, 3DA2352024, 3DA2352025, 3DB2362026, 3DB2422029

The hazard

According to the FDA, when the PET-CT system is executing reconstruction, if PET acquisition for another patient is performed or PET reconstruction for another patient is performed from raw data processing, PET reconstruction control processing may hang up and PET reconstruction may stop as a result. This malfunction may necessitate repeat PET/CT examinations.

Context

GovInfoNow's records show Canon Medical System USA Inc. has 26 other recalls on record since April 18, 2018. Other recent recalls of similar products include Canon Alphenix X-ray Systems Recall (Aug. 4, 2026), Canon Vantage Titan 3T MRI Systems Recall (Dec. 19, 2025), and Canon Alphenix INFX-8000H X-ray System Recall (Dec. 19, 2025).

How to tell if you have this one

Check for the model numbers PCD-1000A/3D.004 or PCD-1000A/3D on the scanner. Serial numbers start with 3DA20 (e.g., 3DA2072002) or 3DA22Y/3DA22Z (e.g., 3DA22Y2017).

Brand
Canon Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Scanner Model
Identify the model number on the scanner, which should be PCD-1000A/3D.004 or PCD-1000A/3D.
Contact Manufacturer
Reach out to Canon Medical System, USA, INC. for further guidance on the specific model and serial number.

Where it went and when

Where it was distributed

Distributed in 18 states.

FDA distribution: “US: NV, AR, MN, IA, IL, NC, LA, KS, MS, CA, AL, MD, CO, IN, TN, AZ, WI, VA” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Minnesota, Mississippi, Nevada, North Carolina, Tennessee, Virginia, Wisconsin.

Recall timeline

FDA published this recall 57 days after the firm started it.

Sep 17, 2024Firm started the recall
Nov 1, 2024FDA classified it Class II
Nov 13, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/54017-canon-cartesion-prime-pet-ct-recall-pet-reconstruction-may-hang">Canon Cartesion Prime PET-CT Recall: PET Reconstruction May Hang During Scans (GovInfoNow)</a>

Where this comes from

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-0284-2025 (September 17, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0284-2025 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.