Sfx-90 Table/Spotfilmer W/Fluoricon L200

• • Terminated Z-2179-2017 FDA Class II ·initiated 6 Feb 2017 ·on shared 510(k) K801320

  Reported incidents of a patient step detaching from the table. A fall from a patient step detaching while in use could result in an injury to a patient or operator.

• • Terminated Z-0916-2017 FDA Class II ·initiated 21 Nov 2016

  GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems.

• • Terminated Z-0804-2014 FDA Class II ·initiated 8 Nov 2013

  Missing screws in the overhead Video Monitor Suspension. GE discovered that the 4 outer screws that hold the overhead Video Monitor Suspension to the carriage were missing since installation of the system. GE is not aware of any fall of the overhead monitor suspension.

• • Terminated Z-0012-2014 FDA Class II ·initiated 30 Aug 2013

  GE Healthcare has recently become aware of a potential safety issue involving the spotfilm device power assist handle. There is a potential for the internal bolts on the power assist handle to be loose or to loosen and/or fall out. This issue, if present, can result in a loss of calibration and offset of the power assist handle and/or, under extreme condition, sticking of the handle in the ON p

• • Terminated Z-0200-2009 FDA Unclassified (pre-2012) ·initiated 9 Mar 2007 ·on shared 510(k) K801320

  GE Healthcare has recently become aware of a potential risk of monitor dropping associated with the monitor suspension of the Advantx system that may impact patient safety. It has been reported that suspensions manufactured after March 8, 1995 did not have the required thread locking agent applied to the setscrew, allowing the setscrew to back out over time, which can lead to the monitor dropping

• 4 recalls, same reason

  • Terminated Z-0853-04 FDA Unclassified (pre-2012) ·initiated 30 Mar 2004 ·on shared 510(k) K801320
  • Terminated Z-0852-04 FDA Unclassified (pre-2012) ·initiated 30 Mar 2004 ·on shared 510(k) K801320
  • Terminated Z-0851-04 FDA Unclassified (pre-2012) ·initiated 30 Mar 2004 ·on shared 510(k) K801320
  • Terminated Z-0850-04 FDA Unclassified (pre-2012) ·initiated 30 Mar 2004 ·on shared 510(k) K801320

  The ball joint that attaches the single monitor platform to the system boom could fail causing the monitor to fall.

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

510(k) Number

K801320 ↗

FDA Product Code

JAA

Device Class

Class II

Regulation

21 CFR Part 892.1650

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

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