Reported Nov 15, 2023 · Ongoing
The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR)…
Carestream Health, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Carestream Health, Inc. · 1049 W Ridge Rd · Rochester, NY · 14615-2731
Is this the product you have?
- The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images outside of standard stationary x-ray room. The DRX-Revolution system incorporates a flat-panel detector that can be used wirelessly for exams such as in-bed chest projections. The system can also be used to expose CR phosphor screens or films.
- Lot codes and dates
- UDI-DI60889971019394
- Serial Numbers
1,432 of 1,432 codes
124332313232323332453246324732483249325032513252325432573260326332643265326632673270327232773285331233133317331833203321332233233324332833343465347034773489349034953496350235033506350935103511351235183521354335463548354935513552355635573563
- UDI-DI60889978618897
- Serial Numbers
970 of 970 codes
700170167021703170327054706070757084708570937094709571147115711671187119714371447145714671477148714971507152715371547155715671577158716071617167716871697170717171727173717471807181718271847185718672037204720872097223722472257233723472357236
- Amount recalled
- 2402 systems
Where it was sold
- Nationwide
Why it was recalled
There is a potential for unexpected failure of the electrical components within the Carestream Health Inc. generator installed in your DRX-Revolution Mobile X-ray System(s). This can lead to temporary and self contained thermal overload within the generator. Should an event like this occur, the system will become inoperable and loud noise, burnt smell and smoke may be detectable.
This product could cause temporary or reversible health problems — stop using it.
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