Recall Record

Schwarzenbruck, Germany

IBA Dosimetry GmbH recalls

1 recall recorded since 2018, most recently on 1 April 2025. 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
1 April 2025
Reason
Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character.
Distribution
Worldwide - US Nationwide distribution in the states of AL, AR, FL, GA, KS, MD, OK and the countries of Algeria, Austria, Belgium, Czech Republic, Denmark, France, Germany, Ireland, Italy, Morocco, Norway, Poland, Slovakia, Spain, Israel, Kazakhstan, Kosovo, Libya, South Africa, Turkey, United Kingd
Initiated
Voluntary: Firm initiated
Recall number
Z-1703-2025

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.