FDA DevicesClass II
MOSAIQ Oncology Information System
Published: June 17, 2026Recall ID: Z-2406-2026Category: devicesCountry: US
Reason for Recall / Hazard
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Product Description & Identification
MOSAIQ Oncology Information System
Additional Source Details
| Field | Value |
|---|---|
| City | Atlanta |
| State | GA |
| Event id | 98980 |
| Address 1 | 400 Perimeter Center Ter NE Ste 50 |
| Address 2 | N/A |
| Code info | Software Version: MOSAIQ 3.2/UDI: 07340201500071 |
| Postal code | 30346-1227 |
| Report date | 20260617 |
| Product type | Devices |
| Product quantity | 12 programs |
| Reason for recall | Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260521 |
| Initial firm notification | Letter |
| Center classification date | 20260611 |
Overview
- Recalling FirmElekta, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution in the states of WI, FL, LA, NY, NY, NJ, KS, FL, IA, NM, TX and the countries of Bahrain, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, Pakistan, Panama, Poland, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom.