Reported Jul 13, 2022 · Ongoing
Omnera 400A Digital Radiographic System
Arcoma AB
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Arcoma AB · Annavagen 1 · Vaxjo, N/A · N/A
Is this the product you have?
- Omnera 400A Digital Radiographic System
- Lot codes and dates
- UDI/DI
073500087500122001-20032006-20442046-20562118-21262128-21312134-21602164-21752177-21952197-22082210-22122214-22242226-2236
- UDI/DI
- Amount recalled
- 47 systems
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
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).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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