Canon Medical System, USA, INC. Recall 89218
Description: Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.
Canon Medical System, USA, INC. Recall 89218 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0492-2022 |
| Event ID | 89218 |
| Event Description | Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of DE, FL, LA, MT, NJ, OH, and WV. |
| Quantity | 8 |
| Recall 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. |
| Device Classification | 20220119 |
| Device Code Info | SID: 30039059, Alphenix System Serial Number: BGC20Y2010, & Flat Panel Detector Serial Number: C1B20Y2215 SID: 30030612, Alphenix System Serial Number: B8D20Z2001, & Flat Panel Detector Serial Number: C1B20Z2218; SID: 30030612, Alphenix System Serial Number: B8D20Z2001, & Flat Panel Detector Serial Number: C1B20Z2219; SID: 30046247, Alphenix System Serial Number: B1B20Z2001, & Flat Panel Detector Serial Number: C1B20Z2221; SID: 30064041, Alphenix System Serial Number: BGD2172011, & Flat Panel Detector Serial Number: C1B2172234; SID: 30065145, Alphenix System Serial Number: B1E2172002, & Flat Panel Detector Serial Number: C1B2172235; SID: 30058149, Alphenix System Serial Number: B1E2152001, & Flat Panel Detector Serial Number: C1B2152230; SID: 30002089, Alphenix System Serial Number: BHC20Z2003, & Flat Panel Detector Serial Number: C1B20Z2217. |
| Center Classification Date | 20220112 |
| Recall Initiation Date | 20211220 |
| Recalling Firm | Canon Medical System, USA, INC. |
| Initial Notification | Letter |
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