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Z-2580-2021 Class II Terminated

Recalled by Biodex Medical Systems, Inc. — Shirley, NY

FDA device recall Z-2580-2021 was initiated by Biodex Medical Systems, Inc. on August 16, 2021 and is designated Class II. Reason for recall: 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 an… The recall status is terminated (terminated May 30, 2024). Affected quantity: 829 units.

Recall Details

Product Type: Devices
Report Date: October 6, 2021
Initiation Date: August 16, 2021
Termination Date: May 30, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 829 units

Product Description

Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.

Reason for Recall

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 Pattern

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 Oman Pakistan Palestine Panama Peru Philippines Poland Portugal PR Puerto Rico Qatar Romania Russia Saudi Arabia Singapore South Africa South Korea Spain Sweden Taiwan UAE United Arab Emirates United Kingdom Venezuela

Code Information

Serial Number range:17081557-21062362 UDI: 00718175003305