MOSAIQ Oncology Information System
Reported: February 19, 2025 Initiated: January 15, 2025 #Z-1162-2025
Product Description
MOSAIQ Oncology Information System
Reason for Recall
Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
Details
- Recalling Firm
- Elekta, Inc.
- Units Affected
- 64 units
- Distribution
- US: PA, AL, FL, IA UT OUS: Austria Belgium Bolivia Bosnia and Herzegowina Brazil Canada France Germany Hong Kong Italy Japan Korea, Republic of Malta Netherlands Panama South Africa Spain Taiwan Thailand Turkey Venezuela
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
MOSAIQ Oncology Information System. Recalled by Elekta, Inc.. Units affected: 64 units.
Why was this product recalled? ▼
Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 19, 2025. Severity: Moderate. Recall number: Z-1162-2025.
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