Canon Medical PET-CT System Software Malfunction Prevents Image Reconstruction
27 Canon Cartesion Prime PET-CT imaging systems may experience software processing failures during simultaneous imaging of multiple patients, necessitating repeat examinations. The issue occurs when PET acquisition or reconstruction for another patient is performed while reconstruction is in progress.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA classified this as Class II. No illnesses, injuries, or hospitalizations are reported in the source. The software malfunction causes operational failure requiring repeat imaging, which is an inconvenience rather than a direct patient safety hazard. Per the rubric, with no reported injuries and an operational defect, this rates Moderate (Score 2).
Plain-English summary
Canon Medical System, USA, INC. is recalling 27 units of the Cartesion Prime PET-CT diagnostic imaging system (Models PCD-1000A/3D.004 and PCD-1000A/3D). The system combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) imaging for diagnostic purposes.
The recall is due to a software control malfunction affecting image reconstruction. When the system is executing PET reconstruction, if PET acquisition or PET reconstruction for another patient is performed simultaneously, the reconstruction control processing may hang and stop. This malfunction necessitates repeat PET/CT examinations.
The affected systems are distributed to medical facilities across 18 US states: Nevada, Arkansas, Minnesota, Iowa, Illinois, North Carolina, Louisiana, Kansas, Mississippi, California, Alabama, Maryland, Colorado, Indiana, Tennessee, Arizona, Wisconsin, and Virginia. The issue affects units running software versions V10.8 SP0013 or V10.15 SP0006, with specific serial numbers identified by the manufacturer. This is a Class II FDA medical device recall (Recall No. Z-0284-2025).
The recalled product
- 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.
- Manufacturer
- Canon Medical System, USA, INC.
- Affected units
- 27
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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