Recall Z-1703-2025— IBA Dosimetry GmbH

Name: FDA recall Z-1703-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-01

Class II · Ongoing

Class II FDA medical device recall by IBA Dosimetry GmbH, initiated 2025-04-01. It names one FDA 510(k) clearance: K201798. Product: myQA iON; Article Number: MQ10-000;. Reason: Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character..

Recalling firm: IBA Dosimetry GmbH
Classification: Class II
Status: Ongoing
Initiated: 2025-04-01
Firm location: Schwarzenbruck, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K201798 — myQA iONIba Dosimetry GmbH·cleared 2020-07-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

myQA iON; Article Number: MQ10-000;

Reason for recall

Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character.

Data sourced from openFDA. This site is unofficial and independent of the FDA.