Siemens Enhanced Imaging System

• • Terminated Z-0061-2017 FDA Class II ·initiated 16 Aug 2013

  The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically by four linear bearing cars. There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.

• • Terminated Z-1086-2015 FDA Class II ·initiated 23 Oct 2012

  There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.

• 2 recalls, same reason

  • Terminated Z-0583-2010 FDA Unclassified (pre-2012) ·initiated 11 Dec 2009
  • Terminated Z-0584-2010 FDA Unclassified (pre-2012) ·initiated 11 Dec 2009 ·on shared 510(k) K041166

  Some of the hand controllers of the Symbia S & T systems are missing a resistor switch, and the absence of the switch may lead to unintended system motion during camera set up activities.

• 2 recalls, same reason

  • Terminated Z-1676-2009 FDA Unclassified (pre-2012) ·initiated 22 Apr 2009
  • Terminated Z-1677-2009 FDA Unclassified (pre-2012) ·initiated 22 Apr 2009

  The pinion gear could crack and cause the gantry to spin freely thereby damaging the Symbia S or T System and potentially injuring a patient during a scan.

• 2 recalls, same reason

  • Terminated Z-1649-2009 FDA Unclassified (pre-2012) ·initiated 11 Mar 2009
  • Terminated Z-1648-2009 FDA Unclassified (pre-2012) ·initiated 11 Mar 2009

  Patient injury can occur when the patient is lying on the patient bed and the automatic collimator exchanger is undergoing a collimator change operation at the launch of an acquisition workflow. Detector motions required for this change can cause collision with the patient or pallet if it is in brain scan position, i.e. the patient or pallet is into the field of view.

• 2 recalls, same reason

  • Terminated Z-0190-2009 FDA Unclassified (pre-2012) ·initiated 29 Sep 2008
  • Terminated Z-0189-2009 FDA Unclassified (pre-2012) ·initiated 29 Sep 2008

  The protective plastic cap over the CT gantry power switch on the Line Connection Box may come loose, exposing the energized electrical contacts within the switch, thereby causing an electric hazard.

• 2 recalls, same reason

  • Terminated Z-0548-2007 FDA Unclassified (pre-2012) ·initiated 30 Jan 2007
  • Terminated Z-0549-2007 FDA Unclassified (pre-2012) ·initiated 30 Jan 2007 ·on shared 510(k) K041166

  Symbia systems, running on e.soft version 5.5 or earlier, could allow a fully-extended patient pallet to come into contact with the pinhole collimator, resulting in system damage.

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

1. 29 Sep 2008 Recall initiated FDA recalls Z-0190-2009
2. 29 Sep 2008 Recall initiated FDA recalls Z-0189-2009
3. 11 Mar 2009 Recall initiated FDA recalls Z-1649-2009
4. 11 Mar 2009 Recall initiated FDA recalls Z-1648-2009
5. 22 Apr 2009 Recall initiated FDA recalls Z-1676-2009
6. 22 Apr 2009 Recall initiated FDA recalls Z-1677-2009
7. 11 Dec 2009 Recall initiated FDA recalls Z-0583-2010
8. 11 Dec 2009 Recall initiated FDA recalls Z-0584-2010
9. 23 Oct 2012 Recall initiated FDA recalls Z-1086-2015
10. 16 Aug 2013 Recall initiated FDA recalls Z-0061-2017

3 earlier events are in the sections above.

510(k) Number

K041166 ↗

FDA product code

KPS

Device class

Class II

Regulation

21 CFR Part 892.1200

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Other devices filed under FDA product code KPS (System, Tomography, Computed, Emission).

• POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W by Shimadzu Medical Systems
• QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT) by Smv America
• QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION by Ge Medical Systems F.I. Haifa
• TRIAD NUCLEAR IMAGING SYSTEM by Trionix Research Laboratory, Inc.
• NEUROQ - PET DP by Syntermed, Inc.
• Discovery NM/CT 670 CZT by GE Healthcare
• CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS by Nuccardiac Software, Inc.
• WBR XPRESS PET by Ultraspect, Ltd.
• CEQUAL-QUANTITATIVE ANALYSIS by Nuccardiac Software, Inc.
• VANTAGE 2.1 EXSPECT by Adac Laboratories

• Symbia Intevo Bold combination

  Class IIb

  CE/MDR

• Biograph Vision 600 Combination

  Class IIb

  CE/MDR

• CS-20-1 Uniform Phantom Combi

  Class IIb

  CE/MDR

• Biograph Vision Quadra Combination

  Class IIb

  CE/MDR

See all devices from Siemens Medical Solutions USA, Inc. →