The Recall Desk
HighFDA (Devices)·Z-0492-2022·Announced 2022-01-19

Flat Panel Detector May Display Abnormal Images During Surgical Procedures

Canon Medical's flat panel detectors used in Alphenix surgical systems may display abnormal horizontal stripes and fail to recover by restarting, potentially causing operators to work without proper visual guidance during procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with no reported injuries or illnesses. The hazard is a risk-of-harm product where serious injury (blood vessel damage) has not yet been reported, fitting the rubric criterion for Score 3 (High).

Plain-English summary

Canon Medical System, USA, INC. is recalling eight Flat Panel Detector Model TFP-800A units used with Alphenix surgical imaging systems. These detectors may display abnormal images with horizontal stripes or fail to display proper images, and may not recover when the system is restarted.

When operators encounter a non-functional or degraded image display during a surgical procedure, they may inadvertently continue working without proper visual guidance. In the worst case, an operator may remove a catheter from a patient's blood vessel without adequate visualization, which could result in damage to the blood vessel.

The affected devices were distributed nationwide to healthcare facilities in Delaware, Florida, Louisiana, Montana, New Jersey, Ohio, and West Virginia. No injuries or illnesses have been reported in connection with this recall.

The recalled product

Product
Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.
Manufacturer
Canon Medical System, USA, INC.
Category
Medical Device — Diagnostic Imaging Equipment
Hazard
  • display-malfunction
  • vessel-injury

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)

  • 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
  • & 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

Distribution

Distributed nationwide across the United States.

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