Product Safety Recalls

Product Recall Tracker

Biodex Medical Systems, Inc. Recall 88604

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

Biodex Medical Systems, Inc. Recall 88604 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2580-2021
Event ID88604
Event DescriptionAtomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.
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
Quantity829 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:17081557-21062362 UDI: 00718175003305
Center Classification Date20210927
Recall Initiation Date20210816
Recalling FirmBiodex Medical Systems, Inc.
Initial Notification E-Mail
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.