The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2581-2021·Announced 2021-10-06

Dose Calibrator Software Bug May Cause Incorrect Isotope Measurements

AtomLab 500Plus Dose Calibrator software versions 2.0.00–2.0.08 contain a bug that fails to remove dial settings when deleting custom isotopes, potentially causing incorrect dose calibrations and misadministration.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 recall involving a risk-of-harm product where incorrect dose calibration and misadministration of radioactive material could occur. No illnesses or injuries have been reported in the source text, placing this in the 'risk-of-harm products where injury has not yet been reported' category per the rubric.

Plain-English summary

The FDA is recalling AtomLab 500Plus Dose Calibrator software versions 2.0.00 through 2.0.08 (Model 086-332), manufactured by Biodex Medical Systems, Inc. Approximately 429 units have been distributed nationwide and internationally.

The software contains a defect in its custom isotope deletion function. When a user deletes a previously entered custom isotope, the software removes the isotope entry but fails to delete the associated dial setting. This leaves other custom isotopes in the system with incorrect dial settings, which can lead to incorrect dose measurements and potential misadministration of radioactive doses.

The affected software is used in nuclear medicine departments and facilities that rely on the AtomLab 500Plus Dose Calibrator to measure and calibrate radioactive isotope doses for patient administration.

Users of affected software versions should verify their version and contact Biodex Medical Systems, Inc. to determine if an update or patch is available to correct this defect.

The recalled product

Product
AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332
Manufacturer
Biodex Medical Systems, Inc.
Category
Medical Device — Nuclear Medicine Equipment
Hazard
Affected units
429

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:17080651-21061047 UDI: 00718175003329

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Biodex Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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