Recall Z-0492-2022— Canon Medical System, USA, INC.
Class II · Ongoing
Class II FDA medical device recall by Canon Medical System, USA, INC., initiated 2021-12-20. It names 4 FDA 510(k) clearances: K182546, K182415, K181804 and 1 more. Product: Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.. Reason: 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..
- Recalling firm
- Canon Medical System, USA, INC.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-12-20
- Firm location
- Tustin, CA, United States
510(k) clearances named in this recall
4 on FDA's record- K182546 — Alphenix, INFX-8000H/B, V8.0
- K182415 — Alphenix, INFX-8000F/B, V8.0
- K181804 — Alphenix, INFX-8000C/B, V8.0
- K181670 — Alphenix, INFX-8000V/B, V8.0
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.