Recall Z-0360-2020— Canon Medical System, USA, INC.
Class II · Terminated
Class II FDA medical device recall by Canon Medical System, USA, INC., initiated 2019-02-08, terminated 2022-06-07. It names one FDA 510(k) clearance: K081624. Product: Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (Interventional Angiography System), to position patient during diagnostic and interventional x-ray angiography.. Reason: Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit..
- Recalling firm
- Canon Medical System, USA, INC.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-02-08
- Terminated
- 2022-06-07
- Firm location
- Tustin, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (Interventional Angiography System), to position patient during diagnostic and interventional x-ray angiography.
Reason for recall
Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit.
Data sourced from openFDA. This site is unofficial and independent of the FDA.