Symbia, Version 4.0

• 2 recalls, same reason

  • Terminated Z-2713-2014 FDA Class II ·initiated 28 Jul 2014
  • Terminated Z-2712-2014 FDA Class II ·initiated 28 Jul 2014

  Siemens Medical Solutions USA, Inc. is performing a field correction because we recently detected a rubber isolator with unfavorable aging properties. The function of the rubber isolator, which is situated within the rotate motor mounting assembly, may degrade over time and may impact motor support. The event does not pose a hazard by itself but could lead to a rupture of the drive belt which in t

• • Terminated Z-0960-2015 FDA Class II ·initiated 5 Mar 2014

  There are confirmed reports of a component coming loose inside the CT enclosure and damaging the system. components.

• • Terminated Z-0115-2015 FDA Class II ·initiated 28 Oct 2013

  Reports of loose bolts in the detector support structure of Symbia and E.CAM systems.

• • Terminated Z-0062-2017 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-1087-2015 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-0283-2012 FDA Unclassified (pre-2012) ·initiated 14 Oct 2011
  • Terminated Z-0284-2012 FDA Unclassified (pre-2012) ·initiated 14 Oct 2011 ·on shared 510(k) K082506

  Errors could potentially impact image interpretation. The acquisition software is exhibiting a defect in the energy window position when an isotope is peaked. There is a potential patient safety issue when running syngo MI Applications version VA60A with Foresight detectors firmware version v1.5.9.12 on the Symbia systems.

• • Terminated Z-2980-2011 FDA Unclassified (pre-2012) ·initiated 22 Jun 2011

  There a potential patient safety issue when using the Symbia Radiation Therapy Pallet. When a patient is not iso-centered before starting a scan with the Symbia T Series Systems and a non-circular orbit is selected, it is possible that one of the detectors may come into contact with the patient.

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

1. 21 Nov 2008 Cleared FDA 510(k) K082506
2. 22 Jun 2011 Recall initiated FDA recalls Z-2980-2011
3. 14 Oct 2011 Recall initiated FDA recalls Z-0283-2012
4. 14 Oct 2011 Recall initiated FDA recalls Z-0284-2012
5. 23 Oct 2012 Recall initiated FDA recalls Z-1087-2015
6. 16 Aug 2013 Recall initiated FDA recalls Z-0062-2017
7. 28 Oct 2013 Recall initiated FDA recalls Z-0115-2015
8. 5 Mar 2014 Recall initiated FDA recalls Z-0960-2015
9. 28 Jul 2014 Recall initiated FDA recalls Z-2713-2014
10. 28 Jul 2014 Recall initiated FDA recalls Z-2712-2014

510(k) Number

K082506 ↗

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

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