Canon Medical System, USA, INC.: Medical Device Recall in 2024 - (Recall #: Z-0284-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 17, 2024

Date Posted: November 13, 2024

Recall Number: Z-0284-2025

Event ID: 95471

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.

Status: Ongoing

Product Quantity: 27

Code Information:

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

Distribution Pattern:

US: NV, AR, MN, IA, IL, NC, LA, KS, MS, CA, AL, MD, CO, IN, TN, AZ, WI, VA

Voluntary or Mandated:

Voluntary: Firm initiated