Kodak Directview Dr 7500 System, Model 8791345

• • Terminated Z-2177-2014 FDA Class II ·initiated 9 Jul 2014

  An on-site evaluation of the equipment parts that attach the Beta Assembly (x-ray tube and collimator) to the Over Head Tube Crane (OTC) Telescope was completed by Carestream Health (CSH) Service Engineering. Inspection of these parts revealed that the tab on the lock washer was not bent into the lock nut recess and because the Beta Assembly detached from the OTC telescope, the lock nut was not sufficiently tightened.

• • Terminated Z-0844-2014 FDA Class II ·initiated 26 Dec 2013

  Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to a possible patient image display error.

• • Terminated Z-0798-2014 FDA Class II ·initiated 25 Nov 2013 ·on shared 510(k) K051258

  Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.

• • Terminated Z-0738-2007 FDA Unclassified (pre-2012) ·initiated 6 Mar 2007

  The x-ray systems do not indicate the field size when the system's detector is turned off and the collimator is in manual mode. This results in the systems being noncompliant with the field indication performance standards of section 1020.31(e)(2)& (3) of 21Code of Federal Regulations (CFR).

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

510(k) Number

K051258 ↗

FDA Product Code

KPR

Device Class

Class II

Regulation

21 CFR Part 892.1680

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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