Omnera 400T Digital Radiographic System recallZ-1331-2022 · Arcoma AB · initiated May 5, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Arcoma AB or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1331-2022
- Status
- Open, Classified
- Initiated by the company
- May 5, 2021
- Posted by the FDA
- Jul 5, 2022
- Recalling firm
- Arcoma AB
- Quantity
- 71 systems
- Product code
- KPR
- FDA submissions
- K140683
- 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.
Product description
Omnera 400T Digital Radiographic System
Code information (models, lots, serial numbers)
UDI/DI:07350008750050; 2001-2003, 2006-2044, 2046-2056, 2118-2126, 2128-2131, 2134-2160, 2164-2175, 2177-2195, 2197-2208, 2210-2212, 2214-2224, 2226-2236.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- OMNERA 400T 0180Arcoma AB · Solid State X-Ray Imager (Flat Panel/Digital Imager)1 recall1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 90446).
- Z-1332-2022 · Open, ClassifiedOmnera 400A Digital Radiographic System
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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