Cartesion Prime — Class II medical device recall Z-0284-2025
Ongoing recall by Canon Medical System, USA, INC., reported 2024-11-13, distributed in AL, AR, AZ, CA, CO, IA, IL, IN…. When PET-CT system is executing reconstruction, if PET acquisition for another patient is performed (or PET re
| Recall number | Z-0284-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Canon Medical System, USA, INC., Tustin, CA, United States |
| Recall initiated | 2024-09-17 |
| Classified | 2024-11-01 |
| Reported by FDA | 2024-11-13 |
| Distributed | AL, AR, AZ, CA, CO, IA, IL, IN, KS, LA, MD, MN, MS, NC, NV, TN, VA, WI |
| Quantity | 27 |
| UPC / GTIN / UDI-DI | 04987670103810 |
| 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 and 2 more |
| Model numbers | PCD-1000A/3D, PCD-1000A/3D.004 |
Product
Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Reason for 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0284-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.