Z-1838-2021 Class II Terminated
FDA device recall Z-1838-2021 was initiated by RAYSEARCH LABORATORIES AB on April 21, 2021 and is designated Class II. Reason for recall: Evaluation of a clinical goal for the voxelwise worst dose distributions may be misleading after editing the clinical goal. It also describes an issue with contouring when the spacing between slices i… The recall status is terminated (terminated July 27, 2023). Affected quantity: Domestic: 13,722 systems.
Recall Details
- Product Type
- Devices
- Report Date
- June 16, 2021
- Initiation Date
- April 21, 2021
- Termination Date
- July 27, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Domestic: 13,722 systems
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AK, AL, AZ, CA, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, Colombia, Czech Republic, Denmark, Egypt, Estonia, France, French Polynesia, Germany, Hong Kong, China, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK,