CLASS II Device recall · Reported 6 Oct 2021 · FDA Enforcement Report

AtomLab 500Plus Dose CalibratorSoftware 0.00 through recalled

Biodex Medical Systems is recalling AtomLab 500Plus Dose CalibratorSoftware 0.00 through Revision 0.08, inclusive, distributed nationwide in the US. The recall was initiated on 16 Aug 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Number Range:17080651-21061047 UDI: 00718175003329

Quantity recalled429 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2581-2021
FDA event ID: 88604
Recalling firm: Biodex Medical Systems, Shirley, NY
Classification: Class II
Status: Terminated
Recall initiated: 16 Aug 2021
FDA classified: 27 Sep 2021
Reported: 6 Oct 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Lead & Heavy Metals
Device type: Medical Software

Timeline

16 Aug 2021	Recall initiated by company
27 Sep 2021	Classified by FDA	+42 days
6 Oct 2021	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332

Where it was distributed

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

Nationwide Puerto Rico

Questions about this recall

Is AtomLab 500Plus Dose CalibratorSoftware 0.00 through Revision 0.08, inclusive recalled?

Yes. Biodex Medical Systems recalled AtomLab 500Plus Dose CalibratorSoftware 0.00 through Revision 0.08, inclusive on 16 Aug 2021. The recall is Class II and its status is Terminated. Recall number Z-2581-2021.

Why was it recalled?

Which lots are affected?

Serial Number Range:17080651-21061047 UDI: 00718175003329

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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Reported	Class	Recall	Company	Reason	Where
6 Oct 2021Device	CLASS II	Atomlab 500 Dose Calibrator recalled by Biodex Medical Systems	Biodex Medical Systems	Lead & Heavy Metals	Nationwide

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