Symbia 6.0

• • Terminated Z-2758-2016 FDA Class II ·initiated 5 Aug 2016 ·on shared 510(k) K142006

  "We have received reports of patients hair being caught in the e.cam and Symbia E patient bed up/down drive. The purpose of this letter is to remind users of the patient positioning instructions for your e.cam or Symbia E system and to inform you of an update that will be performed by your local Siemens service representative."

• • Terminated Z-2898-2020 FDA Class II ·initiated 31 Mar 2016

  E. CAM and Symbia system with foresight detectors performing gated or dynamic acquisition may lose some detector time information. Our risk analysis indicates that the probability of occurrence is remote. SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. CT: The CT component is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial place taken at different angles or spiral planes taken at different angles. SPECT+CT: Perform CT scans and nuclear imaging studies within the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.

• 2 recalls, same reason

  • Terminated Z-1262-2016 FDA Class II ·initiated 26 Feb 2016
  • Terminated Z-1263-2016 FDA Class II ·initiated 26 Feb 2016

  We received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-00002). The result of a Hazard Analysis and CAPA investigation, we have determined that for e.cam or Symbia E systems that although the existing user manual is correct, additional supplemental instructions, with the inclusion of visual aids, may further clarify and emphasize the proper collimator change

• • Terminated Z-0687-2016 FDA Class II ·initiated 31 Dec 2015 ·on shared 510(k) K142006

  To provide operator instruction manuals for the e.cam Dual Signature; Gamma Camera that were not sent in its entirety when the e.cam systems were refurbished and shipped to the customer.

• 3 recalls, same reason

  • Terminated Z-2437-2015 FDA Class II ·initiated 31 Jul 2015
  • Terminated Z-2436-2015 FDA Class II ·initiated 31 Jul 2015
  • Terminated Z-2435-2015 FDA Class II ·initiated 31 Jul 2015

  Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. These fuses, in conjunction with a specific failure mode of the Power Controller assembly, could lead to the overheating of the assembly.

• • Terminated Z-0208-2016 FDA Class II ·initiated 26 Jun 2015

  Potential failure mode related to the radial brake, where the detector was able to drift, led to a re-design of the brake redundancy circuit. The redesigned Brake Redundancy Circuit will force even a defective brake to engage in the unpowered state by applying a reverse charge to the brake and ensuring the brake has demagnetized.

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

1. 21 Aug 2014 Cleared FDA 510(k) K142006
2. 26 Jun 2015 Recall initiated FDA recalls Z-0208-2016
3. 31 Jul 2015 Recall initiated FDA recalls Z-2437-2015
4. 31 Jul 2015 Recall initiated FDA recalls Z-2436-2015
5. 31 Jul 2015 Recall initiated FDA recalls Z-2435-2015
6. 31 Dec 2015 Recall initiated FDA recalls Z-0687-2016
7. 26 Feb 2016 Recall initiated FDA recalls Z-1262-2016
8. 26 Feb 2016 Recall initiated FDA recalls Z-1263-2016
9. 31 Mar 2016 Recall initiated FDA recalls Z-2898-2020
10. 5 Aug 2016 Recall initiated FDA recalls Z-2758-2016

510(k) Number

K142006 ↗

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

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

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. →