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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2580-2021 |
| Event ID | 88604 |
| Event Description | Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330. |
| Product Type | Devices |
| 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 |
| Quantity | 829 units |
| Recall Reason | 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 |
| Device Classification | 20211006 |
| Device Code Info | Serial Number range:17081557-21062362 UDI: 00718175003305 |
| Center Classification Date | 20210927 |
| Recall Initiation Date | 20210816 |
| Recalling Firm | Biodex Medical Systems, Inc. |
| Initial Notification | |
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