CLASS II ONGOING Device recall · Reported 19 Jan 2022 · FDA Enforcement Report
Flat Panel Detector recalled by Canon Medical System, USA
Canon Medical System USA is recalling Flat Panel Detector, distributed nationwide in the US. The recall was initiated on 20 Dec 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0492-2022
- FDA event ID
- 89218
- Recalling firm
- Canon Medical System USA, Tustin, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Dec 2021
- FDA classified
- 12 Jan 2022
- Reported
- 19 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 20 Dec 2021 | Recall initiated by company | |
| 12 Jan 2022 | Classified by FDA | +23 days |
| 19 Jan 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.
Where it was distributed
US Nationwide distribution in the states of DE, FL, LA, MT, NJ, OH, and WV.
Nationwide FloridaLouisianaMontanaNew JerseyOhioWest Virginia
Questions about this recall
Why was it 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.
Which lots are affected?
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.
Where was it sold?
US Nationwide distribution in the states of DE, FL, LA, MT, NJ, OH, and WV.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Canon Medical System USA
All 51| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Alphenix Infx-8000C/B5 recalled by Canon Medical System USA | Canon Medical System USA | Other | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled | Canon Medical System USA | Other | Nationwide |
| Device | CLASS II | Alphenix Infx-8000C, interventional fluoroscopic x-ray system recalled | Canon Medical System USA | Device Malfunction | Nationwide |
| Device | CLASS II | Alphenix Infx-8000V, interventional fluoroscopic x-ray system recalled | Canon Medical System USA | Device Malfunction | Nationwide |
| Device | CLASS II | Alphenix Infx-8000H, interventional fluoroscopic x-ray system recalled | Canon Medical System USA | Device Malfunction | Nationwide |
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