Omnera 400T Radiographic System Recalled for Potential Overhead Crane Malfunction
Arcoma AB is recalling 71 Omnera 400T radiographic systems because liquid ingress in the display handles may cause electrical short circuits and uncontrolled movement of the overhead tube crane.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II medical device constituting a risk-of-harm product (X-ray system with overhead crane component). Hazard is theoretical with no reported illnesses or injuries, meeting the rubric criterion for High severity.
Plain-English summary
Arcoma AB is recalling 71 Omnera 400T Digital Radiographic Systems distributed nationwide throughout the United States and Canada. These are X-ray imaging systems used in medical facilities.
The recalled systems may develop an electrical short circuit due to liquid ingress in the display handles. This short circuit may cause uncontrolled movement of the Overhead Tube Crane (OTC), a component of the radiographic system.
Customers who own a recalled system should stop using the equipment immediately and contact Arcoma AB for repair or replacement instructions. The recalled systems can be identified by their UDI/DI codes and serial number ranges.
The recalled product
- Product
- Omnera 400T Digital Radiographic System
- Manufacturer
- Arcoma AB
- Affected units
- 71
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: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.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Arcoma AB under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Arcoma AB
See all →- HighOmnera 400A Digital Radiographic System: Electrical Short Circuit Hazard
FDA (Devices) · 2022-07-13
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