Biodex Medical Systems, Inc.: Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.

Is my product affected?

Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.

• UPC 00718175003305

Check against the official notice below — it lists the full affected range.

What happened

Biodex Medical Systems is recalling Atomlab 500 Dose Calibrator software versions 2.0.00 through 2.0.08 (Model 086-330). The software has a defect where deleting a custom isotope removes the isotope but leaves its associated dial setting in place. This can cause other stored custom isotopes to have incorrect dial settings, potentially resulting in incorrect dose measurements and misadministration of medication. The recall affects 829 units distributed nationwide and internationally, with serial numbers ranging from 17081557 to 21062362.

The recall record does not specify what action affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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 Distribution: 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 Sau Quantity: 829 units Lot/code info: Serial Number range:17081557-21062362 UDI: 00718175003305

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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