Recall Z-1289-2022 ยท OWB Interventional Fluoroscopic X-Ray System
Canon Medical System, USA, INC.
System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW
| Date | Jun 24, 2022 (initiated May 3, 2022) |
| Status | Open, Classified |
| Reason | CT operation may be restricted by an interlock which is a result of an system error and the CT system may stop operating properly after an attempt to cancel the error message has been initiated. |
| Root cause | Software design |
| Action | On or about 04/20/2022, Canon Medical Systems USA, Inc sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter informing customer of a potential issue with your ALPHENIX System when used in combination with a CT system where the CT operations may be restricted by an interlock which is a result of an error "H29 M. Net error. The Error message(s) Gantry reached inner limit or Gantry reached out limit may be seen on the CT System at the time of occurence. The CT system may stop operating properly after an attempt to cancel the error message has been initiated. The error may result in the patien |
| Quantity | 6 systems |
| Distribution | U.S.: CA, CO, FL, NY, and WY O.U.S.: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181804 | Alphenix, INFX-8000C/B, V8.0 Canon Medical Systems Corporation, Aug 2, 2018 |