MOSAIQ Oncology Information System
Reported: October 6, 2021 Initiated: September 2, 2021 #Z-2591-2021
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.
Details
- Recalling Firm
- Elekta, Inc.
- Units Affected
- 31
- Distribution
- 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.
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
MOSAIQ Oncology Information System. Recalled by Elekta, Inc.. Units affected: 31.
Why was this product recalled? ▼
A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 6, 2021. Severity: Moderate. Recall number: Z-2591-2021.
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