The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2651-2017·Announced 2017-07-05

Carestream Recalls DRX-Revolution Mobile X-Ray Systems Due to Assembly Defect

Carestream Health Inc is recalling DRX-Revolution Mobile X-Ray Systems because missing screws could cause the tube and yoke assembly to separate.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect that could lead to the separation of heavy components, posing a risk of harm, although no injuries have been reported.

Plain-English summary

Carestream Health Inc is recalling the DRX-Revolution Mobile X-Ray System, Model DRXR-1. The recall involves 1,449 units distributed domestically and 1,416 units distributed internationally. The affected units are identified by serial numbers 101 through 2623 (worldwide except China) and 800101 through 800482 (China only).

The recall was initiated after Carestream identified a single unit where four screws in the assembly were not applied during the manufacturing process. This defect could result in the separation of the tube and yoke assembly. The agency has classified this recall as Class II.

Healthcare facilities and users of the affected mobile X-ray systems should contact Carestream Health Inc for instructions on how to resolve the issue. The product is used to generate and control X-rays for diagnostic procedures.

The recalled product

Product
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
Manufacturer
Carestream Health Inc
Category
Medical Device — Imaging Equipment
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same manufacturer · Carestream Health Inc

See all →

Same hazard · structural failure

See all →

Similar recalls