Class 2 Device Recall Omnera

• Date Initiated by Firm: May 05, 2021
• Date Posted: July 05, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1332-2022
• Recall Event ID: 90446
• 510(K)Number: K140683
• Product Classification: System, x-ray, stationary - Product Code KPR
• Product: Omnera 400A Digital Radiographic System
• Code Information: UDI/DI: 07350008750012; 2001-2003, 2006-2044, 2046-2056, 2118-2126, 2128-2131, 2134-2160, 2164-2175, 2177-2195, 2197-2208, 2210-2212, 2214-2224, 2226-2236.
• Recalling Firm/ Manufacturer: Arcoma AB; Annavagen 1; Vaxjo Sweden
• For Additional Information Contact: Gary Becker; 800-4211968
• Manufacturer 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).
• FDA Determined 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 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.
• Quantity in Commerce: 47 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KPR