Z-2117-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 7, 2019
- Initiation Date
- June 7, 2019
- Termination Date
- April 28, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7
Product Description
Peak Vest, Single Item, Product Number PVest, Part Numbers REPVEST*M, SEPVESTE, SEPVEST*F 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.
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
Code Information
Serial Numbers: 418892 381887 381902 418811 418952 387916 429678