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Recall Observatory FDA recall evidence

Device product

Overlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFVEST*M, REFVESTE, REFVESTXLM, SEFVEST*F, SEFVEST*M

Z-2115-2019

June 07, 2019

Class II

Product summary

Firm
Burlington Medical, LLC
Event
Event 83144
Status
Terminated
Classification
Class II
Quantity
7
Official record key
device-enforcement:Z-2115-2019

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: 385688 387953 385694 385696 387781 384424 382874

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.