Omnera 400T Digital Radiographic System recall
Omnera 400T Digital Radiographic System
Why was Omnera 400T Digital Radiographic System 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).
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Omnera 400T Digital Radiographic System
- Recalling firm
- Arcoma AB
- 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.
- Recall date
- July 13, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)