FDA Device recall Z-0284-2025
Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission Tomo…
- FDA Device
- Class II
- ongoing
- Published 2024-11-13
On 2024-11-13 the FDA classified a Class II recall of Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission Tomo… by Canon Medical System Usa, citing 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 processin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0284-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-17 |
| Published | 2024-11-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Canon Medical System Usa |
| Distribution | AL, AR, AZ, CA, CO, IA, IL, IN, KS, LA, MD, MN, MS, NC, NV, TN, VA, WI |
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
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.
Identifiers
| code_info | UDI-DI: 04987670103810, Software: V10.8 SP0013, V10.15 SP0006. Serial Numbers: 3DA1982001, 3DA2072002, 3DA2072003, 3DA…UDI-DI: 04987670103810, 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0284-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.