Z-0360-2020 Class II Terminated
FDA device recall Z-0360-2020 was initiated by Canon Medical System, USA, INC. on February 8, 2019 and is designated Class II. Reason for recall: Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit. The recall status is terminated (terminated June 7, 2022). Affected quantity: 9 systems.
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2019
- Initiation Date
- February 8, 2019
- Termination Date
- June 7, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 systems
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.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AL, CT, FL, IL, OR, PA, and TX; and country of Netherlands.
Code Information
Model CAT-870B D053991 Serial No. Manufacture Date 99D08X2101 October 2008 99D0582039 August 2005 99D0762072 June 2007 99D0852090 May 2008 99D07Y2078 November 2007 99D0812081 January 2008 99D0582042 August 2005 99D0552033 May 2005 D551206 May 2005