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U.S. Department of Health and Human Services

Class 2 Device Recall Biodex

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  Class 2 Device Recall Biodex see related information
Date Initiated by Firm August 16, 2021
Create Date September 27, 2021
Recall Status1 Completed
Recall Number Z-2581-2021
Recall Event ID 88604
510(K)Number K090296  
Product Classification Calibrator, dose, radionuclide - Product Code KPT
Product AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332
Code Information Serial Number Range:17080651-21061047 UDI: 00718175003329
Recalling Firm/
Manufacturer		 Biodex Medical Systems, Inc.
20 Ramsey Rd
Shirley NY 11967-4704
For Additional Information Contact SAME
800-224-6339 Ext. 2343
Manufacturer 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
FDA Determined
Cause 2		 Software design
Action Biodex issued Urgent Medical Deice Recall Letter on 8/16/21 via email. Letter states reason for recall, health risk and action to take: Review the dial settings associated with custom isotope and confirm they have not been changed. Compare the measured activity with a dose calibrator from another manufacturer The error can be immediately corrected by restarting the system. We recommend that you promptly download new software. The error is corrected in Software Revision 2.0.10. The corrected software upgrade is available as a download from the Biodex website at the following link Atomlab 500 Dose Calibrator Software Update v2.0.10 - Software Updates - Nuclear Medicine | Biodex. System registration is required for download. Please email us at supportservices@biodex.com to acknowledge receipt of this letter and confirm commitment to download the software update. To minimize risk of illness or injury, please download the software correction, as soon as possible. If you have any questions or require any additional information, please contact supportservices@biodex.com.
Quantity in Commerce 429 units
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 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPT and Original Applicant = BIODEX MEDICAL SYSTEMS, INC.
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