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Recall Observatory FDA recall evidence

Device product

1 pc Full Wrap Back Relief Apron, Product Number B52 Front & Back Apron, Part Numbers SEB52*F, UEB52*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-2120-2019

June 07, 2019

Class II

Product summary

Firm
Burlington Medical, LLC
Event
Event 83144
Status
Terminated
Classification
Class II
Quantity
2
Official record key
device-enforcement:Z-2120-2019

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: 395561 395557

Distribution pattern: US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.