Device product
Frontal Stretch Buckle Closure Apron, Product Number A-10, Part Numbers REA10A, REA10B, REA10C, REA10*F, REA10*M, UEA10*M Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
Z-2107-2019
Product summary
- Event
- Event 83144
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9
- Official record key
device-enforcement:Z-2107-2019
Official wording
Reason: The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Code information: Serial Numbers: 423604 423524 423537 423549 387906 423539 423577 444669 384383
Distribution pattern: US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
Derived failure modes
-
Unknown
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.