O-Arm Imaging System

• • Terminated Z-1932-2019 FDA Class II ·initiated 1 May 2019

  The 0-arm 1000 Imaging System uses energy from the batteries to generate X-rays and move the system. If a charger board is not functioning properly, the batteries will not receive a full recharge of the potential capacity and results in the inability of the system to take X-rays, open the gantry, and move the system from one place to another, which may affect the ability to continue use within the operating room until the charger board and/or the batteries are replaced

• 10 recalls, same reason

  • Terminated Z-0277-2019 FDA Class II ·initiated 30 Aug 2018
  • Terminated Z-0280-2019 FDA Class II ·initiated 30 Aug 2018
  • Terminated Z-0272-2019 FDA Class II ·initiated 30 Aug 2018
  • Terminated Z-0279-2019 FDA Class II ·initiated 30 Aug 2018
  • Terminated Z-0276-2019 FDA Class II ·initiated 30 Aug 2018
  • Terminated Z-0271-2019 FDA Class II ·initiated 30 Aug 2018
  • Terminated Z-0275-2019 FDA Class II ·initiated 30 Aug 2018
  • Terminated Z-0278-2019 FDA Class II ·initiated 30 Aug 2018
  • Terminated Z-0273-2019 FDA Class II ·initiated 30 Aug 2018
  • Terminated Z-0274-2019 FDA Class II ·initiated 30 Aug 2018

  Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, and logs generation. Software version 3.1.7 will be installed on all 2nd edition imaging systems.

• • Terminated Z-0928-2018 FDA Class II ·initiated 25 Jan 2018

  Software update ("SW Update 3.2.1") is being implemented to address the following issues: Inability to power the system after shutdown, System stays in standalone mode, Image reconstruction, System/Pendant bootup, Dose display/report, Gantry motion, Network communication, System shutdown, and Early termination of 3D spin.

• • Terminated Z-2082-2016 FDA Class II ·initiated 17 Mar 2016

  It has been discovered that replacement x-ray generator and system motion batteries could become damaged during shipment, resulting in unacceptable risk of failure.

• • Terminated Z-0973-2014 FDA Class II ·initiated 25 Jul 2013

  Review of on-system electronic product labeling and Instructions for comply with applicable Use in response to a customer inquiry uncovered gaps in compliance FDA standards with the requirements for information to be provided to users in 21CFR 1020.30(h)

• • Terminated Z-0926-2013 FDA Class II ·initiated 31 Jan 2013

  Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction

• • Terminated Z-2244-2012 FDA Class II ·initiated 11 Jul 2012

  A fault in a high voltage relay in the 0-arm Imaging System might cause the relay to overheat and burn.

• • Terminated Z-0447-2011 FDA Unclassified (pre-2012) ·initiated 15 Oct 2010 ·on shared 510(k) K092564

  Safety Notice: Door Cable Periodic Maintenance Schedule and Cable Wear for the O-ARM Imaging System Breakage of the door cable during opening and closing may occur and cause physical harm or delay of therapy

• • Terminated Z-1849-2012 FDA Class II ·initiated 12 Oct 2010 ·on shared 510(k) K092564

  Software Version 3.1.1 does not meet navigational accuracy.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K092564 ↗

FDA Product Code

OXO

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent