Device product
Burlington Medical, Demi Half Aprons.
Z-1763-2026
Product summary
- Event
- Event 98415
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 29 units
- Official record key
device-enforcement:Z-1763-2026
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: R8DHALFR; UDI-DI (Product Code): 00197513001485 (DHALF8-R8DHALFR-L), 00197513001478 (DHALF8-R8DHALFR-M), 00197513001461 (DHALF8-R8DHALFR-S), 00197513001492 (DHALF8-R8DHALFR-XL), 00197513001607 (DHALFSET8-R8DHALFR-SET).
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.