CLASS II Device recall · Reported 20 Aug 2014 · FDA Enforcement Report
Kodak DirectView DR 7500 Diagnostic X-Ray System recalled
Carestream Health is recalling Kodak DirectView DR 7500 Diagnostic X-Ray System, distributed nationwide in the US. The recall was initiated on 9 Jul 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2177-2014
- FDA event ID
- 68727
- Recalling firm
- Carestream Health, Rochester, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Jul 2014
- FDA classified
- 9 Aug 2014
- Reported
- 20 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Processing Deviation
- Device type
- Imaging Equipment
Timeline
| 9 Jul 2014 | Recall initiated by company | |
| 9 Aug 2014 | Classified by FDA | +31 days |
| 20 Aug 2014 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Why was it 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 lots are affected?
The device can be tracked according to service code. The service code for the DR 7500 system is 8087.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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