FDA Device recall Z-2177-2014
Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system compo…
- FDA Device
- Class II
- terminated
- Published 2014-08-20
On 2014-08-20 the FDA classified a Class II recall of Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system compo… by Carestream Health, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2177-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-09 |
| Published | 2014-08-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Carestream Health |
| Distribution | US |
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
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.
Identifiers
| code_info | The device can be tracked according to service code. The service code for the DR 7500 system is 8087. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2177-2014%22
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