Reported Aug 20, 2014 · Terminated
Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a permanently installed…
Carestream Health, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Carestream Health, Inc. · 1049 W Ridge Rd · Rochester, NY · 14615-2731
Is this the product you have?
- Kodak DirectView DR 7500
- Diagnostic X-Ray System Product UsageThe DR 7500 system is a permanently installed diagnostic x-ray
- system composed of 4 main componentsan 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
- Lot codes and dates
- The device can be tracked according to service code. The service code for the DR 7500 system is 8087.
- Amount recalled
- 589 systems
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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