Canon Medical System, USA, INC.: Medical Device Recall in 2022 - (Recall #: Z-0492-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.

Product Classification:

Class II

Date Initiated: December 20, 2021

Date Posted: January 19, 2022

Recall Number: Z-0492-2022

Event ID: 89218

Reason for Recall:

Abnormal images such as horizontal stripes may be displayed and recovery may not not be possible by restarting the system. The worst case scenario is an operator who is working without a workable image may remove a catheter from the patient's blood vessel and damage the blood vessel.

Status: Ongoing

Product Quantity: 8

Code Information:

SID: 30039059, Alphenix System Serial Number: BGC20Y2010, & Flat Panel Detector Serial Number: C1B20Y2215 SID: 30030612, Alphenix System Serial Number: B8D20Z2001, & Flat Panel Detector Serial Number: C1B20Z2218; SID: 30030612, Alphenix System Serial Number: B8D20Z2001, & Flat Panel Detector Serial Number: C1B20Z2219; SID: 30046247, Alphenix System Serial Number: B1B20Z2001, & Flat Panel Detector Serial Number: C1B20Z2221; SID: 30064041, Alphenix System Serial Number: BGD2172011, & Flat Panel Detector Serial Number: C1B2172234; SID: 30065145, Alphenix System Serial Number: B1E2172002, & Flat Panel Detector Serial Number: C1B2172235; SID: 30058149, Alphenix System Serial Number: B1E2152001, & Flat Panel Detector Serial Number: C1B2152230; SID: 30002089, Alphenix System Serial Number: BHC20Z2003, & Flat Panel Detector Serial Number: C1B20Z2217.

Distribution Pattern:

US Nationwide distribution in the states of DE, FL, LA, MT, NJ, OH, and WV.

Voluntary or Mandated:

Voluntary: Firm initiated