PET-CT SCANNER PCD-1000ARecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K132813, K143294, K191582, K202349, K203314, K231748, K251370); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Sep 17, 2024Open, Classified

   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.

   Z-0284-2025 · Root cause: Software design · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132813, K143294, K191582, K202349, K203314, K231748, K251370. One submission often covers many models, so check the product and lot details in each record.

• Z-0142-2022 · Nov 11, 2020 · Terminated
  Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A