Reported Jan 19, 2022 · Ongoing
Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C,…
Canon Medical System, USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Canon Medical System, USA, INC. · 2441 Michelle Dr · Tustin, CA · 92780-7047
Is this the product you have?
- Flat Panel Detector
- Model NumberTFP-800A, used with the Alphenix Systems
- Item Numbers
INFX-8000VINFX-8000CINFX-8000Fand INFX-8000H
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 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 2 SID: 30030612, Alphenix System Serial Number: B8D20Z2001, & Flat Panel Detector Serial Number: C1B20Z2219 3 SID: 30046247, Alphenix System Serial Number: B1B20Z2001, & Flat Panel Detector Serial Number: C1B20Z2221 4 SID: 30064041, Alphenix System Serial Number: BGD2172011, & Flat Panel Detector Serial Number: C1B2172234 5 SID: 30065145, Alphenix System Serial Number: B1E2172002, & Flat Panel Detector Serial Number: C1B2172235 6 SID: 30058149, Alphenix System Serial Number: B1E2152001, & Flat Panel Detector Serial Number: C1B2152230 7 SID: 30002089, Alphenix System Serial Number: BHC20Z2003, & Flat Panel Detector Serial Number: C1B20Z2217. - Amount recalled
- 8
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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