Z-2345-2021 Class II Terminated
FDA device recall Z-2345-2021 was initiated by Philips North America Llc on July 30, 2021 and is designated Class II. Reason for recall: Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury The recall status is terminated (terminated July 25, 2023). Affected quantity: 11 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 1, 2021
- Initiation Date
- July 30, 2021
- Termination Date
- July 25, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, MD, MD, NH, NY, OH, TN, TX, VA and the countries of Canada, Mexico, Australia, Austria, Chile, China, Czech Republic, Denmark, France, Germany, India, Indonesia, Italy, Japan, Korea, Republic of Lebanon, Netherlands, Romania, Russian Federation, Saudi Arabia, Spain, Turkey, Ukraine, United Kingdom.