Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608
Reported: February 15, 2017 Initiated: January 12, 2017 #Z-1138-2017
Product Description
Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608
Reason for Recall
The firm received a complaint alleging that a DRX Revolution System could not be stopped when applying the brake. The Revolution crashed into an elevator.
Details
- Recalling Firm
- Carestream Health Inc
- Units Affected
- US: 1403 units; Foreign: 1370 units
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico, and to the countries of : Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Denmark, Dominican Republic, Dubai, Finland, France, Germany, Ghana, India, Iran, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Libya, Malaysia, Maldives, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates and United Kingdom.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608. Recalled by Carestream Health Inc. Units affected: US: 1403 units; Foreign: 1370 units.
Why was this product recalled? ▼
The firm received a complaint alleging that a DRX Revolution System could not be stopped when applying the brake. The Revolution crashed into an elevator.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 15, 2017. Severity: Moderate. Recall number: Z-1138-2017.
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