Vaxjo, N/A, Sweden
Arcoma AB recalls
1 recall recorded since 2018, most recently on 5 May 2021. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 5 May 2021
- Reason
- 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).
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1332-2022, Z-1331-2022
- Omnera 400A Digital Radiographic System
- Omnera 400T Digital Radiographic System
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.