Recall Z-0360-2020 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Canon Medical System, USA, INC.
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.
| Date | Feb 8, 2019 |
| Status | Terminated |
| Reason | Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit. |
| Root cause | Error in labeling |
| Action | On 02/08/2019, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Notification to customers via USPS return receipt mail informing them of the potential problem with the Catheterization Table (CAT-870B) may tilt without operator involvement due to accidental liquid spillage. Customers are instructed to: a. Please keep the tableside console and the x-ray detector of the support units covered with sterile caps as stated in the Caution section of the operation manual. The caps are there to prevent liquids from coming into contact with the tableside console and the x-ray detector. b. If an actu |
| Quantity | 9 systems |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, CT, FL, IL, OR, PA, and TX; and country of Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081624 | INFX-8000F (INFINIX CSI AND INFINIX DPI) Toshiba America Medical Systems, In.C, Jun 23, 2008 |