Severity
Moderate
FDA Devices recall · Reported August 20, 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 Heal…
Carestream Health, Inc. recalled Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system i… - a moderate-severity action.
Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system i… was recalled by Carestream Health, Inc. in August 20, 2014. Reason: An on-site evaluation of the equipment parts that attach the Beta Assembly (x-ray tube and collimator) to the…. Check the official notice for the remedy. Verify recall #Z-2177-2014 with the FDA Devices before acting.
The recall
Carestream Health, Inc. issued this moderate-severity FDA Devices recall-An on-site evaluation of the equipment parts that attach the Beta Assembly (x-ray tube and collimator) to the….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2177-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2177-2014) was formally reported on August 20, 2014, with the manufacturer initiating the action on July 9, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Carestream Health, Inc. is listed as the recalling firm, operating out of Rochester, NY. Federal records list the affected scope as 589 systems.
The documented reason for this recall is: 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. Inspecti… Distribution data in the federal record shows the product reached: 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, Ita…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
589 systems
Related Recalls
6
3 from same agency
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.
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.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2177-2014 |
| Date reported | August 20, 2014 |
| Date initiated | July 9, 2014 |
| Recalling firm | Carestream Health, Inc. |
| Firm location | Rochester, NY |
| Affected scope | 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 Kon… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 20, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.