GE 3.0T Signa Infinity Twinspeed with Excite MR System

• • Ongoing Z-0613-2022 FDA Class II ·initiated 23 Dec 2021

  The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

• 3 recalls, same reason

  • Terminated Z-0112-2019 FDA Class II ·initiated 7 Jun 2018
  • Terminated Z-0111-2019 FDA Class II ·initiated 7 Jun 2018
  • Terminated Z-0110-2019 FDA Class II ·initiated 7 Jun 2018

  The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch.

• • Terminated Z-2339-2015 FDA Class II ·initiated 10 Jul 2015

  A gradient cable in the ACGD cabinet may be missing a spacer that prevents connecting the gradient cable terminals in the wrong polarity on X gradient amplifier. This could cause images to be flipped left-right with incorrect orientation annotation.

• • Terminated Z-1305-2015 FDA Class II ·initiated 9 Mar 2015

  GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites.

• • Terminated Z-1035-2015 FDA Class I ·initiated 7 Jan 2015

  At certain sites, the MRU may not be connected to the magnet. In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. The MRU must be connected to the magnet at all times.

• • Terminated Z-1943-2013 FDA Class II ·initiated 21 Nov 2011

  Screen save images are included in wrong exam due to duplicate UID creation. This may cause a safety issue due to a potential patient data mismatch.While the issue has only been observed at one customer site on the Signa HDxT 1.5T system, internal investigation revealed that the issue also impacts multiple GE healthcare MR Systems.

• • Terminated Z-1431-2011 FDA Unclassified (pre-2012) ·initiated 9 Nov 2010

  GE Healthcare has become aware of a potential issue associated with the gradient cables being inadvertently swapped while servicing the gradients on some GE Healthcare MR Systems that may impact patient safety. If the gradient cables are inadvertently swapped while servicing the gradients, and the Service Engineer does not perform the geometry check as required in the service procedure, images m

510(k) Number

K030874 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Generator, High Volt, X-Ray, Diag. MPX80

  Class I

  FDA 510(k) K802548 Active Cleared 2 Dec 1980

• Senograph Ds, Senograph Essenstial

  Class II

  FDA 510(k) K103485 Active Cleared 6 Oct 2011

• Senographe Ds, Senographe Essential

  Class II

  FDA 510(k) K110798 Active Cleared 22 Dec 2011

• GE CT/T 8800 System

  Class II

  FDA 510(k) K780326 Active Cleared 14 Mar 1978

• CT Pace Catalog Number B7950A

  Class II

  FDA 510(k) K872526 Active Cleared 23 Sep 1987

• Series 620 Rectal Probe Cover

  Class II

  FDA 510(k) K864222 Active Cleared 4 Mar 1987

See all devices from General Electric Co. →

• What is the GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR System used for?

  This device is a magnetic resonance imaging (MRI) system designed for diagnostic imaging applications, as defined in the device data. It is intended for use in radiology settings to produce detailed images of internal body structures for clinical evaluation.

• How was the GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR System cleared for market?

  The device received FDA 510(k) clearance under submission number K030874 on March 28, 2003, based on a determination of substantial equivalence to a legally marketed predicate device. It is classified as a Class II medical device under regulation number 892.1000.

• Who manufactures the GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR System and where is it based?

  The system is manufactured by General Electric Co., with the applicant and manufacturer listed as General Electric Co. The device’s registration and FEI numbers are associated with facilities in Milwaukee, Wisconsin, United States, as indicated by the address, city, state, postal code, and country code in the data.