Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.
Reported: January 19, 2022 Initiated: December 20, 2021 #Z-0492-2022
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.
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.
Details
- Recalling Firm
- Canon Medical System, USA, INC.
- Units Affected
- 8
- Distribution
- US Nationwide distribution in the states of DE, FL, LA, MT, NJ, OH, and WV.
- Location
- Tustin, CA
Frequently Asked Questions
What product was recalled? ▼
Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.. Recalled by Canon Medical System, USA, INC.. Units affected: 8.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on January 19, 2022. Severity: Moderate. Recall number: Z-0492-2022.
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