Health product recall

Elekta Unity, Philips Marlin Software (2020-05-01)

Starting date:
May 1, 2020
Posting date:
June 26, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-73427



Last updated: 2020-06-29

Affected Products

Elekta Unity, Philips Marlin Software

Reason

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.

Affected products

Elekta Unity, Philips Marlin Software

Lot or serial number
  • Software ver.: R5.3.30
  • Software ver.: R5.3.31
  • Software ver.: R5.7.0
  • Software ver.: R5.7.1
  • Software ver.: R6.0.5331
  • Software ver.: R6.1.571
Model or catalog number

1536549

Companies
Manufacturer

Elekta Limited

Linac House, Fleming Way

Crawley, Sussex

RH10 9RR

UNITED KINGDOM