PlainRecalls
FDA Devices Moderate Class II Terminated

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 vario

Reported: August 20, 2014 Initiated: July 9, 2014 #Z-2177-2014

Product Description

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.

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.

Details

Recalling Firm
Carestream Health, Inc.
Units Affected
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.
Location
Rochester, NY

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Carestream Health, Inc.. Units affected: 589 systems.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 20, 2014. Severity: Moderate. Recall number: Z-2177-2014.

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