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.
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.
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.
The PET-CT system may hang during reconstruction processing if another patient's PET data is being processed. This can cause the scan to stop unexpectedly, requiring the entire scan to be repeated.
Patients using the recalled PET-CT scanners for medical imaging are affected. Healthcare facilities that own or operate these specific models are most at risk of repeat scans.
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).
Identify the model number on the scanner, which should be PCD-1000A/3D.004 or PCD-1000A/3D.
Reach out to Canon Medical System, USA, INC. for further guidance on the specific model and serial number.
The PET-CT system may hang during reconstruction processing if another patient's PET data is being processed, potentially requiring repeat scans.
Check for model numbers PCD-1000A/3D.004 or PCD-1000A/3D and serial numbers starting with 3DA20 or 3DA22Y/3DA22Z.
No, the recall does not require immediate stop use; the issue may only cause occasional hangs requiring repeat scans.
We’ve drafted a message you can send Canon Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0284-2025 — Canon Medical Canon Medical Hello, I own a Canon Medical that is covered by recall Z-0284-2025 from Canon Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
