Device product
AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332
Z-2581-2021
Product summary
- Event
- Event 88604
- Status
- Terminated
- Classification
- Class II
- Quantity
- 429 units
- Official record key
device-enforcement:Z-2581-2021
Official wording
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
Code information: Serial Number Range:17080651-21061047 UDI: 00718175003329
Distribution pattern: 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
Derived failure modes
-
Device software or design
software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may