Device product
Burlington Medical, Half Aprons.
Z-1762-2026
Product summary
- Event
- Event 98415
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 402 units
- Official record key
device-enforcement:Z-1762-2026
Official wording
Reason: Potential for attenuation degradation over time, decreasing the lifespan.
Code information: All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8HALF1B; UDI-DI (Product Code): 00840331272291 (HALF18-R8HALF1B). 2. Model Number: R8HALF1H; UDI-DI (Product Code): 00840331272314 (HALF18-R8HALF1H). 3. Model Number: R8HALF2B; UDI-DI (Product Code): 00840331272338 (HALF28-R8HALF2B). 4. Model Number: R8HALF2H; UDI-DI (Product Code): 00840331272345 (HALF28-R8HALF2H). 5. Model Number: R8HALF3B; UDI-DI (Product Code): 00840331272352 (HALF38-R8HALF3B). 6. Model Number: R8HALF3H; UDI-DI (Product Code): 00840331272369 (HALF38-R8HALF3H). 7. Model Number: R8HALF4B; UDI-DI (Product Code): 00840331272376 (HALF48-R8HALF4B). 8. Model Number: R8HALF4H; UDI-DI (Product Code): 00840331272383 (HALF48-R8HALF4H). 9. Model Number: R8HALF5B; UDI-DI (Product Code): 00840331272390 (HALF58-R8HALF5B). 10. Model Number: R8HALF5H; UDI-DI (Product Code): 00840331272406 (HALF58-R8HALF5H). 11. Model Number: R8HALF6B; UDI-DI (Product Code): 00840331272420 (HALF68-R8HALF6B). 12. Model Number: R8HALF6H; UDI-DI (Product Code): 00840331272352 (HALF68-R8HALF6H). 13. Model Number: R8HALFSETB; UDI-DI (Product Code): 00840331272413 (HALFSET8-R8HALFSETB). 14. Model Number: R8HALFSETH; UDI-DI (Product Code): 00840331272420 (HALFSET8-R8HALFSETH). 15. Model Number: S8HALF1H; UDI-DI (Product Code): 00840331272451 (HALF18-S8HALF1H). 16. Model Number: S8HALF2B; UDI-DI (Product Code): 00840331272475 (HALF28-S8HALF2B). 17. Model Number: S8HALF2H; UDI-DI (Product Code): 00840331272482 (HALF28-S8HALF2H). 18. Model Number: S8HALF3B; UDI-DI (Product Code): 00840331272499 (HALF38-S8HALF3B). 19. Model Number: S8HALF3H; UDI-DI (Product Code): 00840331272505 (HALF38-S8HALF3H). 20. Model Number: S8HALF4B; UDI-DI (Product Code): 00840331272512 (HALF48-S8HALF4B). 21. Model Number: S8HALF4H; UDI-DI (Product Code): 00840331272529 (HALF48-S8HALF4H). 22. Model Number: S8HALF5B; UDI-DI (Product Code): 00840331272536 (HALF58-S8HALF5B). 23. Model Number: S8HALF5H; UDI-DI (Product Code): 00840331272543 (HALF58-S8HALF5H). 24. Model Number: S8HALF6H; UDI-DI (Product Code): 00840331272499 (HALF68-S8HALF6H). 25. Model Number: S8HALFSETH; UDI-DI (Product Code): 00840331272567 (HALFSET8-S8HALFSETH). 26. Model Number: U8HALF3B; UDI-DI (Product Code): 00840331272635 (HALF38-U8HALF3B). 27. Model Number: U8HALF3H; UDI-DI (Product Code): 00840331272642 (HALF38-U8HALF3H). 28. Model Number: U8HALF4H; UDI-DI (Product Code): 00840331272666 (HALF48-U8HALF4H). 29. Model Number: U8HALF5H; UDI-DI (Product Code): 00840331272680 (HALF58-U8HALF5H). 30. Model Number: U8HALF6H; UDI-DI (Product Code): 00840331272635 (HALF68-U8HALF6H).
Distribution pattern: Worldwide distribution. Nationwide distribution in the US and international distribution to Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, and Vietnam.
Derived failure modes
-
Unknown
Potential for attenuation degradation over time, decreasing the lifespan.