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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77250

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 25, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Carestream Health Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2651-2017
Recall number
Z-2651-2017
Initiated
May 25, 2017
Classification
Class II
Status
Terminated
Recalling firm
Carestream Health Inc
Quantity
Domestic: 1449 units; Foreign: 1416 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

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.