Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The… — Class II medical device recall Z-2177-2014
Terminated recall by Carestream Health, Inc., reported 2014-08-20, distributed nationwide. An on-site evaluation of the equipment parts that attach the Beta Assembly (x-ray tube and collimator) to the
| Recall number | Z-2177-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carestream Health, Inc., Rochester, NY, United States |
| Recall initiated | 2014-07-09 |
| Classified | 2014-08-09 |
| Reported by FDA | 2014-08-20 |
| Terminated | 2017-05-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CH, CN, CZ, DE, DK, ES, FI, FR, GB, HK, IL, IT, KR, KW, NL, NZ, OM, PL, PT, SE, TR, TW, ZA |
| Quantity | 589 systems |
| Reason classes | device malfunction |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2177-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.