The Recall Desk
HighFDA (Devices)·Z-2580-2021·Announced 2021-10-06

Atomlab 500 Dose Calibrator Software Recall for Incorrect Dose Measurement

Biodex Medical Systems is recalling Atomlab 500 Dose Calibrator Software versions 2.0.00 through 2.0.08 due to a software defect that can cause incorrect dose measurements and potential misadministration of radioactive material.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device with potential for incorrect radioactive dose measurement and misadministration. No illnesses or injuries have been reported. The hazard is a software defect that could lead to patient harm through incorrect calibration.

Plain-English summary

Biodex Medical Systems, Inc. is recalling the Atomlab 500 Dose Calibrator Software (versions 2.0.00 through 2.0.08, Model 086-330) due to a software defect. Approximately 829 units have been distributed nationwide and internationally.

The software contains a defect that occurs when a previously entered custom isotope is deleted. While the software deletes the isotope entry, it does not delete the associated dial setting. This can cause other stored custom isotopes to have incorrect dial settings, potentially leading to incorrect dose measurement and misadministration of radioactive material.

The recalled product

Product
Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.
Manufacturer
Biodex Medical Systems, Inc.
Category
Medical Device — Dose Calibrator / Nuclear Medicine
Hazard
  • incorrect-dose-measurement
  • software-defect
  • misadministration

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial Number range:17081557-21062362 UDI: 00718175003305

Distribution

Distributed nationwide across the United States.

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