February 11, 2025

Feb

FDA Recall: Image offsets Calculations May be Incorrect for Linear Accelerator

February 11, 2025Allison PateNews

Company: Elekta, Inc. Date of Enforcement Report: 2/11/2025 Class II PRODUCT MOSAIQ Oncology Information System Recall Number: Z-1162-2025 REASON: Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale. RECALLING FIRM/MANUFACTURER: Elekta, Inc. VOLUME OF PRODUCT IN COMMERCE: 64 units DISTRIBUTION: US: PA, AL, FL,...

FDA Recall: Image offsets Calculations May be Incorrect for Linear Accelerator

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FDA Recall: Image offsets Calculations May be Incorrect for Linear Accelerator

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