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Recall Observatory FDA recall evidence

Device product

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

Z-1138-2017

January 12, 2017

Class II

Product summary

Firm
Carestream Health Inc
Event
Event 76134
Status
Terminated
Classification
Class II
Quantity
US: 1403 units; Foreign: 1370 units
Official record key
device-enforcement:Z-1138-2017

Official wording

Reason: 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.

Code information: Serial Numbers: 101 to 2545 (Worldwide except China), 800101 to 800468 (China only)

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.