URGENT MEDICAL DEVICE RECALL – Atomlab™ 500 Dose Calibrator and Atomlab™ 500Plus Dose Calibrator
August 24, 2021
Biodex is voluntarily recalling the Atomlab™ 500 Dose Calibrator and the Atomlab™ 500Plus Dose Calibrator. The recall is revision 2.0.00 through Revision 2.0.08, inclusive. The Atomlab™ Dose Calibrators are intended to measure the activity of a radioactive source of a known isotope. This measurement may be for purposes of determining or verifying a radiopharmaceutical dose.
Affected Serial Numbers are listed below:
- Device Serial Number Range Atomlab™ 500 Dose Calibrator 17081557 – 21062362
- Atomlab™ 500Plus Dose Calibrator 17080651 – 21061047
Reason for the Voluntary Recall
When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Thus, it is possible other stored custom isotopes may then have incorrect dial settings. The software error is limited to the custom isotope module only and does not affect any other module or the 99 preset dial values.
Risk to Health
An incorrect dial setting may lead to an incorrect dose measurement and/or misadministration. How to recognize software error: 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. Actions to be Taken by the Customer/Distributor: 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: www.biodex.com/software-update/atomlab500. System registration is required for download. 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 email@example.com.