Home / Recalls / Elekta Limited / Z-0706-2019

Z-0706-2019 Class II

Recalled by Elekta Limited — Crawley

Recall Details

Product Type
Devices
Report Date
January 16, 2019
Initiation Date
January 4, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 units

Product Description

Elekta Unity

Reason for Recall

In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and weakening of speaker fixings during the lifetime of the system, the speakers can become dislodged and be pulled into the bore.

Distribution Pattern

TX and WI, Germany, Denmark, Netherlands, United Kingdom

Code Information

Serial Numbers: 1536549, 1536549

Other recalls by Elekta Limited

  • Z-2297-2020 Class II — Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5. (May 21, 2020)
  • Z-1297-2019 Class II — Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Im (April 3, 2019)
  • Z-1109-2019 Class II — Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Un (March 12, 2019)
  • Z-0724-2018 Class II — Integrity R1.2 (November 20, 2017)
  • Z-0723-2018 Class II — Agility with Integrity R3.2 (November 20, 2017)