Apollo Gamma Camera System

• • Ongoing Z-0929-2024 FDA Class I ·initiated 15 Dec 2023

  Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to the patient's lower limbs, as well as an interruption to normal system operation. If detector is positioned above center of gantry, there may be an interruption to normal system operation.

• • Ongoing Z-0677-2024 FDA Class II ·initiated 30 Nov 2023

  While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.

• 3 recalls, same reason

  • Terminated Z-0510-2018 FDA Class II ·initiated 15 Dec 2017
  • Terminated Z-0511-2018 FDA Class II ·initiated 15 Dec 2017
  • Terminated Z-0512-2018 FDA Class II ·initiated 15 Dec 2017

  During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.

• 4 recalls, same reason

  • Terminated Z-1750-2017 FDA Class II ·initiated 24 Feb 2017
  • Terminated Z-1752-2017 FDA Class II ·initiated 24 Feb 2017
  • Terminated Z-1753-2017 FDA Class III ·initiated 24 Feb 2017
  • Terminated Z-1751-2017 FDA Class II ·initiated 24 Feb 2017

  The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.

• 3 recalls, same reason

  • Terminated Z-1480-2017 FDA Class II ·initiated 31 Jan 2017
  • Terminated Z-1481-2017 FDA Class II ·initiated 31 Jan 2017
  • Terminated Z-1479-2017 FDA Class II ·initiated 31 Jan 2017

  Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan

• • Terminated Z-2735-2016 FDA Class II ·initiated 25 May 2016

  The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was caused by a software defect in the workflow setup script.

• 2 recalls, same reason

  • Terminated Z-1021-2016 FDA Class II ·initiated 17 Dec 2015
  • Terminated Z-1020-2016 FDA Class II ·initiated 17 Dec 2015

  The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet. If this occurs, collision sensors would pause the scan. Issue 2: During a scan, the gantry motion may halt prematurely. This cause

• 2 recalls, same reason

  • Terminated Z-1791-2015 FDA Class II ·initiated 6 Mar 2015
  • Terminated Z-1790-2015 FDA Class II ·initiated 6 Mar 2015

  The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

• • Terminated Z-0450-2015 FDA Class II ·initiated 4 Nov 2014

  Software issues

• • Terminated Z-1481-2013 FDA Class II ·initiated 25 Apr 2013

  Philips has received one report from the field that there was an unexpected motion of the detector due to a failure of the mechanical assembly.

• • Terminated Z-2947-2011 FDA Unclassified (pre-2012) ·initiated 15 Jun 2011

  Non-conformances with BrightView X/XCT systems running version 2.0.1 including data transfer, XCT acquisition, Pixel Mask for image reconstruction and table moving incorrectly.

• • Terminated Z-2867-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011 ·on shared 510(k) K062298

  The gap between the two parts of the table may permit pinches to occur on either patients skin or other body parts; it has the potential for serious injury if a patients finger is caught between the pallet and patient table resulting in broken finger bone.

• 5 recalls, same reason

  • Terminated Z-2870-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011
  • Terminated Z-2868-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011
  • Terminated Z-2872-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011
  • Terminated Z-2869-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011
  • Terminated Z-2871-2011 FDA Unclassified (pre-2012) ·initiated 3 Jun 2011

  The gap between the two parts of the table may permit pinches to occur on either patient's skin or other body parts; it has the potential for serious injury if a patient's finger is caught between the pallet and patient table resulting in broken finger bone.

• • Terminated Z-1892-2009 FDA Unclassified (pre-2012) ·initiated 2 Jul 2009

  Unexpected movement-- if the drive assembly is severely compromised, the detector may slide to its hardware limit.

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

510(k) Number

K062298 ↗

FDA Product Code

KPS

Device Class

Class II

Regulation

21 CFR Part 892.1200

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  Class II

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  FDA 510(k) K844298 Active Cleared 1 Mar 1985

• DPS-33000 Nuclear Medicine Imaging Computer

  Class II

  FDA 510(k) K844784 Active Cleared 1 Feb 1985

• Ensphere Tempo Jetstream Workspace Cardiology Module

  Class II

  FDA 510(k) K040142 Active Cleared 6 Feb 2004

• Skylight Imaging System

  Class II

  FDA 510(k) K000908 Active Cleared 5 Apr 2000

• Adac Viewpoint (Additional Software)

  Class II

  FDA 510(k) K884349 Active Cleared 22 Dec 1988

See all devices from Adac Laboratories →