Z-2591-2021 Class II Ongoing
FDA device recall Z-2591-2021 was initiated by Elekta, Inc. on September 2, 2021 and is designated Class II. Reason for recall: A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value. The recall status is ongoing. Affected quantity: 31.
Recall Details
- Product Type
- Devices
- Report Date
- October 6, 2021
- Initiation Date
- September 2, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31
Product Description
MOSAIQ Oncology Information System
Reason for Recall
A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.
Distribution Pattern
Distribution was made to CA, CO, FL, ID, LA, MO, MS, NC, NH, NM, NV, NY, OH, OK, PA, SD, and WA. There was no military/government distribution. Foreign distribution was made to Australia, Canada, and the United Kingdom.
Code Information
MOSAIQ 2.83 when run with First Data Bank (FDB), UDI/GTIN MOSAIQ 2.83 (0858164002367)