Z-2297-2020Class II

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

Name: Z-2297-2020 Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571
Creator: Elekta Limited
Published: 2020-05-21
License: https://open.fda.gov/license/

Elekta Limited / initiated 2020-05-21 / Terminated / root cause: design

FDA source

Elekta Limited began a recall of Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571 on 2020-05-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2297-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-21
Posted: 2020-06-08
Terminated: 2024-08-19
Recalling firm: Elekta Limited
Product: Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 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.
Product codes and lots: Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571. UDI Number 05060191071321. Anatomy (Protocol Name): Abdomen (btFFE Cor RealTime, btFFE Cor Sag RealTime, btFFE Cor Sag Tra RealTime, btFFE Fast Sag Cor RealTime, btFFE Sag RealTime); HeadNeck L (bFFE Cor RealTime, bFFE Cor Sag RealTime, bFFE Cor Sag Tra RealTime, bFFE Sag RealTime, bFFE Sag Tra RealTime); HeadNeck M (bFFE Cor RealTime, bFFE Cor Sag RealTime, bFFE Cor Sag Tra RealTime, bFFE Sag RealTime, bFFE Sag Tra RealTime); Pelvis L (bFFE Cor RealTime, bFFE Cor Sag RealTime, bFFE Cor Sag Tra RealTime, bFFE Sag RealTime, bFFE Sag Tra RealTime); Pelvis M (bFFE Cor RealTime, bFFE Cor Sag RealTime, bFFE Cor Sag Tra RealTime, bFFE Sag RealTime, bFFE Sag Tra RealTime); Thorax (btFFE Cor RealTime, btFFE Cor Sag RealTime, btFFE Cor Sag Tra RealTime, btFFE Sag RealTime, btFFE Sag RealTime)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2297-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2297-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-08

Product code IYE

K192482Class IIElekta UnityElekta Limited / cleared 2019-12-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)