Z-2177-2014Class II

Kodak DirectView DR 7500 Diagnostic X-Ray System

Name: Z-2177-2014 Kodak DirectView DR 7500 Diagnostic X-Ray System
Creator: Carestream Health, Inc.
Published: 2014-07-09
License: https://open.fda.gov/license/

Eastman Kodak Company / initiated 2014-07-09 / Terminated / root cause: design

FDA source

Carestream Health, Inc. began a recall of Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system composed of 4 main... on 2014-07-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2177-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-09
Posted: 2014-08-10
Terminated: 2017-05-12
Recalling firm: Eastman Kodak Company
Product: Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DR 7500 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
Product code: KPR System, X-Ray, Stationary
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: Carestream will notify all DR 7500 customers of the issue and schedule a Field Engineer to inspect and repair the system if required. Specific instructions (Service Modification) for the inspection and repair will followed by the Carestream Field Engineer in order to complete the correction. Documented evidence of the Field Engineer visit will be noted in the Carestream service engineering record for each affected system. Carestream estimates that the plan of correction will be completed within 2-4 weeks
Quantity in commerce: 589 systems
Distribution: Worldwide Distribution - US Nationwide and the countries of (United Kingdom, United Arab Emirates, Turkey, Taiwan, Switzerland, Sweden, Spain, South Africa, Portugal, Poland, Oman, New Zealand, Netherlands, Kuwait, Italy, Israel, Hong Kong, Germany, France, Finland, Denmark, Dubai, Czech Republic, China, Korea, Belgium, Australia, and Amsterdam.
Product codes and lots: The device can be tracked according to service code. The service code for the DR 7500 system is 8087.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2177-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2177-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-09

Product code KPR

K051258Class IIKodak Directview Dr 7500 System, Model 8791345Eastman Kodak Company / cleared 2005-06-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)