Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571

FDA device recall Z-2297-2020 · posted 2020-06-08 · Terminated

Recall details

Recalling firm: Elekta Limited
Reason for recall: In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring images of the monitored structure.
Action taken: Elekta notified customers of the recalls on about 05/21/2020 via "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" letter. Customers were informed that in TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring images of the monitored structure. Instructions included that although there is no method to correct the scaling issue for the affected protocols, the device can still be used under two options: 1. Without the use of Motion Monitoring and 2. compensation for intra-fraction motion can be done through the acquisition of a 3D Verification MRI, which is not impacted by the scaling issue. On 08/05/2020, Elekta issued an additional customer notification to provide additional details of the recall status and to clarify and provide a more generic message regarding the recall issue.
Root cause: Device Design
Status: Terminated
Product code: IYE
Quantity affected: 26 units
Distribution: US distribution to IA, NY, PA, TX, WI. International distribution to Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Turkey, United Kingdom.
Date initiated: 2020-05-21
Date posted: 2020-06-08
Date terminated: 2024-08-19
Location: Crawley, United Kingdom

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Related 510(k) clearances

Record	Firm	Date
Elekta Unity (K192482)	Elekta Limited	2019-12-05