Carestream Health Inc: Medical Device Recall in 2017 - (Recall #: Z-2651-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution --- The DRX-Revolution is a mobile system used to generate and control X-Rays for diagnostic procedures

Product Classification:

Class II

Date Initiated: May 25, 2017

Date Posted: July 5, 2017

Recall Number: Z-2651-2017

Event ID: 77250

Reason for Recall:

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.

Status: Terminated

Product Quantity: Domestic: 1449 units; Foreign: 1416 units

Code Information:

Serial Numbers: Worldwide except China: 101 through 2623; China only: 800101 through 800482

Distribution Pattern:

Worldwide Distribution - US (nationwide) Internationally to Australia, Brazil, Canada, Chile, China, Colombia, Dominican Republic, India, Japan, Israel, Korea, Malaysia, Maldives, Mexico, New Zealand, Peru, Puerto Rico, Singapore, Switzerland, Taipei, Thailand, Turkey, and UAE.

Voluntary or Mandated:

Voluntary: Firm initiated