Shirley, NY, United States
Biodex Medical Systems, Inc. recalls
1 recall recorded since 2018, most recently on 16 August 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 16 August 2021
- Terminated
- 30 May 2024
- Reason
- When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings and may lead to an incorrect dose measurement and/or misadministration
- Distribution
- Nationwide Foreign: Austria Autralia Brazil CANADA Chile Colombia Croatia Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt France Hong Kong HUNGARY Iceland India Iraq Ireland ISRAEL Isreal Italy Japan JORDAN Kuwait Lebanon Libya Malaysia MALTA Mexico Morocco Netherlands New Zealand Oma
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2580-2021, Z-2581-2021
- Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.
- AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332
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.