Z-2917-2018 Class II Terminated
FDA device recall Z-2917-2018 was initiated by Elekta, Inc. on Aug 3, 2018 and is designated Class II. Reason for recall: Order Status Remains Approved When Should Indicate Complete. The recall status is terminated (terminated Sep 23, 2024). Affected quantity: 185.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 29, 2018
- Initiation Date
- Aug 3, 2018
- Termination Date
- Sep 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 185
Product Description
MOSAIQ Oncology Information System
Reason for Recall
Order Status Remains Approved When Should Indicate Complete.
Distribution Pattern
AK, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, WA, WI, WV, and WY Australia, Canada, Ireland, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, and United Kingdom
Code Information
Software Build(s) 2.64 SP3 and higher
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2917-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026