Omnera 400A Digital Radiographic System: Electrical Short Circuit Hazard
Arcoma AB recalls 47 Omnera 400A Digital Radiographic Systems due to potential electrical short circuits that could cause uncontrolled movement of the overhead tube crane.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall for a potential hazard that could cause uncontrolled equipment movement. No illnesses or injuries have been reported. Per the rubric, this qualifies as a risk-of-harm product without reported adverse events, warranting a High (Score 3) severity.
Plain-English summary
Arcoma AB is recalling the Omnera 400A Digital Radiographic System, a medical imaging device used in healthcare settings. A total of 47 systems have been identified in this recall.
The recall addresses a potential safety hazard in which liquid may enter the display handles, potentially causing an electrical short circuit. If this occurs, it could result in uncontrolled movement of the Overhead Tube Crane (OTC), the motorized arm that positions the X-ray tube.
The affected systems were distributed nationwide across 23 U.S. states and Canada. Facilities with affected units should contact Arcoma AB or the FDA for recall information.
The recalled product
- Product
- Omnera 400A Digital Radiographic System
- Manufacturer
- Arcoma AB
- Hazard
- electrical-short
- uncontrolled-movement
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- 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.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Convenience Kits with Lidocaine and Bupivacaine Injections Recalled
FDA (Devices) · 2026-07-01
- HighStryker Neurovascular INZONE Detachment System battery drain
FDA (Devices) · 2026-07-01
- SevereMedline convenience kits recalled for unapproved syringe design changes
FDA (Devices) · 2026-07-01
- HighSurgify Halo surgical drill recalled for potential burr breakage
FDA (Devices) · 2026-07-01
- HighSurgify Halo surgical burr recalled for potential breakage risk
FDA (Devices) · 2026-07-01