Symbia

• 3 recalls, same reason

  • Terminated Z-0913-2015 FDA Class II ·initiated 12 Aug 2014
  • Terminated Z-0912-2015 FDA Class II ·initiated 12 Aug 2014
  • Terminated Z-0911-2015 FDA Class II ·initiated 12 Aug 2014

  Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may cause the patient compression related injuries.

• 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

• 2 recalls, same reason

  • Terminated Z-2043-2014 FDA Class II ·initiated 23 Apr 2014
  • Terminated Z-2042-2014 FDA Class II ·initiated 23 Apr 2014

  Siemens Medical Solutions USA, Inc. has received reports indicating the collimator cart rear casters may become loose.

1. 16 Aug 2013 Cleared FDA 510(k) K131634
2. 23 Apr 2014 Recall initiated FDA recalls Z-2043-2014
3. 23 Apr 2014 Recall initiated FDA recalls Z-2042-2014
4. 28 Jul 2014 Recall initiated FDA recalls Z-2713-2014
5. 28 Jul 2014 Recall initiated FDA recalls Z-2712-2014
6. 12 Aug 2014 Recall initiated FDA recalls Z-0913-2015
7. 12 Aug 2014 Recall initiated FDA recalls Z-0912-2015
8. 12 Aug 2014 Recall initiated FDA recalls Z-0911-2015

510(k) Number

K131634 ↗

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).

• AUTOSPECT PLUS WITH INSTILL MOTION CORRECTION by Adac Laboratories
• uMI uMI Panvivo S by Shanghai United Imaging Healthcare Co., Ltd.
• GE VISION NUCLEAR MEDICINE WORKSTATION by General Electric Co.
• CARDIOMD-AC by Danish Diagnostic Development A/S
• ECAT PET SCANNER by Cti Pet Systems, Inc.
• Hermes Medical Imaging Suite v5.5 by Hermes Medical Solutions AB
• BEACON, MODEL 211060 by Philips Medical Systems (Cleveland), Inc.
• CORT-EX by General Electric Co.
• DISCOVERY NM 630 by GE Healthcare
• MODIFICATION TO WBR, MODEL HR by U.C.G. Technologies, Ltd.

• 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. →