Lightspeed 5.0 Computed Tomography System

• • Terminated Z-1053-2016 FDA Class II ·initiated 10 Feb 2016

  GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.

• • Terminated Z-2801-2015 FDA Class II ·initiated 17 Jul 2015

  Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.

• • Terminated Z-1188-2013 FDA Class II ·initiated 25 Jul 2011

  Fastener bolts on the heat exchanger were not properly torqued and part of the heat exchanger can detach from the gantry and hit the inside of the covers and other components of the gantry possibly resulting in the oil conduit breaking, spilling oil within the gantry and outside the system. This issue affects GE Healthcare VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspe

• • Terminated Z-0804-2007 FDA Unclassified (pre-2012) ·initiated 21 Dec 2006

  Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis.

1. 10 Mar 2003 Cleared FDA 510(k) K030420
2. 21 Dec 2006 Recall initiated FDA recalls Z-0804-2007
3. 25 Jul 2011 Recall initiated FDA recalls Z-1188-2013
4. 17 Jul 2015 Recall initiated FDA recalls Z-2801-2015
5. 10 Feb 2016 Recall initiated FDA recalls Z-1053-2016

510(k) Number

K030420 ↗

FDA product code

JAK

Device class

Class II

Regulation

21 CFR Part 892.1750

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Other devices filed under FDA product code JAK (System, X-Ray, Tomography, Computed).

• AQUILION PRIME, V6.00 by Toshiba Medical Systems
• AQUILION ONE VISION, V6.0 by Toshiba Medical Systems
• Ablation Confirmation by NeuWave Medical, Inc.
• syngo.CT Skull Unfolding by SIEMENS MEDICAL SOLUTIONS USA, INC.
• SCENARIA Phase 3 Whole-body X-ray CT System by Hitachi Medical Systems America, Inc.
• SOMATOM SCOPE/SOMATOM SCOPE POWER by SIEMENS MEDICAL SOLUTIONS USA, INC.
• SYNGO CT ONCOLOGY SOFTWARE PACKAGE by Siemens AG
• MX8000 V5.0 CT SYSTEM by Philips Medical Systems (Cleveland), Inc.
• SYNGO DUAL ENERGY WITH EXTENDED FUNCTIONALLY by Siemens Medi Cal Solutions, Inc.
• MEDIC COLON MODEL, RELEASE 1 by Medicsight

• Enhanced Boundary for PCCT

  Class II

  FDA 510(k) K253560 Active Cleared 24 Jun 2026

• AIR Recon DL

  Class II

  FDA 510(k) K253808 Active Cleared 13 Aug 2026

• Revolution Vibe

  Class II

  FDA 510(k) K250941 Active Cleared 1 Aug 2025

• GenIQ

  Class II

  FDA 510(k) K143368 Active Cleared 29 Jul 2015

See all devices from GE Medical Systems, Inc. →