Elekta Limited: Medical Device Recall in 2020 - (Recall #: Z-2297-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: May 21, 2020

Date Posted: June 17, 2020

Recall Number: Z-2297-2020

Event ID: 85600

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.

Status: Terminated

Product Quantity: 26 units

Code Information:

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)

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated