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DRX-Revolution Mobile X-ray System

by Carestream Health, Inc. 7 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

7 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number60889978007257 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

7 recalls · FDA

    • Terminated Z-2651-2017 FDA Class II initiated 25 May 2017

    Carestream found a single unit where four screws in the assembly were not applied in the manufacturing process. This could result in separation of the tube and yoke assembly.

    • Terminated Z-1138-2017 FDA Class II initiated 12 Jan 2017

    The firm received a complaint alleging that a DRX Revolution System could not be stopped when applying the brake. The Revolution crashed into an elevator.

    • Terminated Z-0800-2015 FDA Class II initiated 25 Nov 2014

    While servicing a unit at a customer site, a field engineer discovered a broken bolt from the carriage assembly. Carestream has identified an issue related to the DRX-Revolution Mobile X-Ray System in which bolts that secure the x-ray tube assembly/boom to the device mounting block may break. It has been determined that this issue is a result of an improperly assembled part which holds the x-ray

    • Terminated Z-0179-2014 FDA Class II initiated 29 Aug 2013

    Carestream Health Inc. has conducted a voluntary field action which includes the installation of a software patch on the following: DRX-Revolution Mobile X-Ray, DRX-Mobile and DRX Transportable Systems with DirectView Version 5.5 and 5.6 console software when used with DRX-1 Detector version 69 firmware. Carestream recently received reports of a non-diagnostic image on exams when a Normal Exposure

    • Terminated Z-0090-2014 FDA Class II initiated 26 Jul 2013

    During an audit, Carestream discovered a DRX-1 System that captured an image which displayed an artifact. This issue was discovered in manufacturing. It occurs when the DRX product console software is updated to v5.6b software and the detector is not calibrated before use.

    • Terminated Z-0132-2014 FDA Class II initiated 19 Jun 2013

    Carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolution Mobile X-Ray System due to the cover dislodging from the column.

    • Terminated Z-0126-2014 FDA Class II initiated 6 Jun 2013

    Carestream Health Inc. is recalling the power plug on their DRX-Revolution Mobile X-Ray System due to the item generating sparks and becoming warm to touch.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Mobile basic diagnostic x-ray system, digital
Model / Ref / Catalog
DRX-Revolution Mobile X-ray System, 8007254
Primary DI / UDI-DI
60889978007257
FDA Product Code
IZL
GMDN Term
Mobile basic diagnostic x-ray system, digital
Device Class
Class II
Regulation Number
892.1720
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K120062)

Other devices from Carestream Health, Inc.

See all devices from Carestream Health, Inc. →

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No