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.
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 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.
- Affected units
- 829
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
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 →Related recalls
Same manufacturer · Biodex Medical Systems, Inc.
See all →- HighDose Calibrator Software Bug May Cause Incorrect Isotope Measurements
FDA (Devices) · 2021-10-06
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