Viva-ProE Systems recall: Software Issue
Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical…
Why was Viva-ProE Systems recalled?
Software malfunction; The action being taken due to the device becoming inoperable due to software lockup.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1. 14-1301 2. 14-1304 3. 14-1308 4. 14-1314 5. 14-1315 6. 14-1323 7. 14-1324 8. 14-1336 9. 15-1328 10. 15-1332 11. 15-1333 12. 15-1334 13. 15-1335 14. 15-1336 15. 15-1337 16. 15-1338 17. 15-1339 18. 16-1301 19. 16-1302 20. 16-1304 21. 16-1305 22. 16-1312 23. 17-1335
- Product
- Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical…
- Recalling firm
- ELITech Group B.V.
- Quantity
- 89 units
- Distribution
- US Nationwide distribution including the state of NY.
- Recall date
- October 9, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)