Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Canon PET-CT SCANNER Recalled by Canon Medical System, USA, INC. Due to A software problem has been identified which could...

Date: November 11, 2020
Company: Canon Medical System, USA, INC.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Canon Medical System, USA, INC. directly.

Affected Products

Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A

Quantity: 3 units

Why Was This Recalled?

A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the diagnostic imaging system failing resulting in rescanning and reinjection of contrast medium.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Canon Medical System, USA, INC.

Canon Medical System, USA, INC. has 49 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report