AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332
Reported: October 6, 2021 Initiated: August 16, 2021 #Z-2581-2021
Product Description
AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332
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
Details
- Recalling Firm
- Biodex Medical Systems, Inc.
- Units Affected
- 429 units
- 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 Saudi Arabia Singapore South Africa South Korea Spain Sweden Taiwan UAE United Arab Emirates United Kingdom Venezuela
- Location
- Shirley, NY
Frequently Asked Questions
What product was recalled? ▼
AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332. Recalled by Biodex Medical Systems, Inc.. Units affected: 429 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 6, 2021. Severity: Moderate. Recall number: Z-2581-2021.
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