Hydradjust IV Urological Table

• • Terminated Z-2833-2018 FDA Class II ·initiated 27 Feb 2017

  Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mode is in the range of 52-65%. The display in all other modes deviated by less than 35% from the dosimeter readings.

• • Terminated Z-1753-2013 FDA Class II ·initiated 25 Apr 2013 ·on shared 510(k) K943581

  A complaint was received in which a hospital physicist indicated the dosage was too high on the HUT system. During the service call the systems Maximum Fluoro Dose was found to be 30 R/min which is three times the Maximum Fluoro Dose limit of 10 R/min.

• • Terminated Z-1904-2010 FDA Unclassified (pre-2012) ·initiated 14 Jun 2010 ·on shared 510(k) K943581

  Covidien received complaints of the Sedecal Generator failing and producing smoke at customer sites. The failure modes are located in different parts of the generator and will lead to the generator becoming inoperative.

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

510(k) Number

K943581 ↗

FDA Product Code

IXR

Device Class

Class II

Regulation

21 CFR Part 892.1980

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Angiomat 6000

  Class II

  FDA 510(k) K860204 Active Cleared 2 May 1986

• Automatic Cassette Loader

  Class II

  FDA 510(k) K902761 Active Cleared 9 Oct 1990

• X-Ray Film, Convey or System

  Class II

  FDA 510(k) K760279 Active Cleared 13 Aug 1976

• Hydrajust IV Urological Table

  Class II

  FDA 510(k) K920742 Active Cleared 27 Apr 1992

• Neuro Vision Radiographic X-Ray System

  Class II

  FDA 510(k) K904146 Active Cleared 13 Dec 1990

• L-F Coiled Extension Tubing

  Class II

  FDA 510(k) K882329 Active Cleared 2 Sep 1988

See all devices from Mallinckrodt Group, Inc. →