Recall Z-1331-2022 ยท KPR System, X-Ray, Stationary
Arcoma AB
Omnera 400T Digital Radiographic System
| Date | Jul 5, 2022 (initiated May 5, 2021) |
| Status | Open, Classified |
| Reason | There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of the Overhead Tube Crane (OTC). |
| Root cause | Device Design |
| Action | On May 7, 2021, Arcoma issued a "Urgent Field Safety Notice". The recall notice asked consignees to take the following actions: Identify the device Take note of amendment/reinforcement of Instructions of Use (IFU) and replace all pages in the Cleaning and disinfection chapter with pages in FSN_2021_01_IFU-EN Rev. 1.1. On May 23, 2022, Arcoma issued a Safety Advisory Notice/ Field Safety Notice via E-Mail informing consignees that they would be updating the display handle with the updated version as an additional safety precaution. Arcoma has requested that Canon Medical System, USA |
| Quantity | 71 systems |
| Distribution | US Nationwide distribution in the states of NM, DE, TX, VT, FL, MO, UT, PA, OR, IN, RI, MI, IL, LA, OH, CO, SC, VA, WA, CA, AZ, NV, AR and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140683 | 0180 INTUITION, 0072 PRECISION Arcoma AB, Jun 3, 2014 |