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Open, Classified

Omnera 400T Digital Radiographic System

FDA Recall Z-1331-2022 · Posted 2022-07-05

Recalling FirmArcoma AB
Recall StatusOpen, Classified
Product CodeKPR
Date Initiated2021-05-05
Product Quantity71 systems

Reason for Recall

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).

Firm 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 ensure that all those who have the affected product, including any others who may need to be informed, receive the safety relevant information provided with this notice and comply with the recommendations herein. A representative of Canon Medical System USA will contact you to schedule a time to replace the display handle with the updated version.

Root Cause

Device Design

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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