Product Safety Recalls

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Biodex Medical Systems, Inc. Recall 88604

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

Biodex Medical Systems, Inc. Recall 88604 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2581-2021
Event ID88604
Event DescriptionAtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332
Product TypeDevices
DistributionNationwide 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
Quantity429 units
Recall ReasonWhen 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
Device Classification20211006
Device Code InfoSerial Number Range:17080651-21061047 UDI: 00718175003329
Center Classification Date20210927
Recall Initiation Date20210816
Recalling FirmBiodex Medical Systems, Inc.
Initial Notification E-Mail
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