CLASS II Device recall · Reported 24 Dec 2014 · FDA Enforcement Report
DRX-Revolution Mobile X-Ray System recalled by Carestream Health
Carestream Health is recalling DRX-Revolution Mobile X-Ray System, distributed nationwide in the US. The recall was initiated on 25 Nov 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0800-2015
- FDA event ID
- 69826
- Recalling firm
- Carestream Health, Rochester, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Nov 2014
- FDA classified
- 12 Dec 2014
- Reported
- 24 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 25 Nov 2014 | Recall initiated by company | |
| 12 Dec 2014 | Classified by FDA | +17 days |
| 24 Dec 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc. The DRX-Revolution Mobile X-Ray System is a mobile imaging system that incorporates a self contained x-ray generator, image receptor, imaging display and software for acquiring medical diagnostic images outside of a standard x-ray room. The DRX-Revolution Mobile X-Ray System has a motor for driving the system so that the operator does not have to push the system, but can walk behind the system while it is moving from one location to another.
Where it was distributed
Worldwide Distribution: US (nationwide) and countries of: AUSTRALIA, BELGIUM, CANADA, CHILE, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, ITALY, JAPAN, KOREA, KUWAIT, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, PALESTINE, PHILIPPINES, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, and UNITED KINGDOM.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Serial Numbers 101 to 764
Where was it sold?
Worldwide Distribution: US (nationwide) and countries of: AUSTRALIA, BELGIUM, CANADA, CHILE, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, ITALY, JAPAN, KOREA, KUWAIT, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, PALESTINE, PHILIPPINES, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, and UNITED KINGDOM.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Carestream Health
All 86| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DRX Revolution Mobile X-Ray System recalled by Carestream Health | Carestream Health | Device Malfunction | Nationwide |
| Device | CLASS II | The DRX-Revolution Mobile X-Ray System is a diagnostic recalled | Carestream Health | Device Malfunction | Nationwide |
| Device | CLASS II | Drx-Compass/Dr-fit X-ray Systems with Firmware recalled | Carestream Health | Other | Nationwide |
| Device | CLASS II | Kodak DirectView DR3000/3500 recalled by Carestream Health | Carestream Health | Other | IA |
| Device | CLASS II | OnSight 3D Extremity System- X-Ray, Tomography Computed System recalled | Carestream Health | Other | Nationwide |
Other Imaging Equipment recalls
All 2,336| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled | Canon Medical System USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederl | Potency & Assay |