FDA-Device2017-06-07Class II
Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems
GE Healthcare, LLC
Hazard
Reported incidents of a patient step detaching from the table. A fall from a patient step detaching while in use could result in an injury to a patient or operator.
Sold states
US: Nationwide including DC and Puerto Rico. OUS: Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Egypt, France, Germany, Greece, Honduras, Hungary, Indonesia, Ireland, Israel, Italy, Jamaica, Jordan, Kuwait, Libya, Malaysia, Malta, Mexico, Panama, Portugal, Russia, Saudi Arabia, Saudi Arabia, Slovakia, Spain, Thailand, United Arab Emirates, United Kingdom, Vietnam.
Affected count
2,380 (2,215 US; 165 OUS)
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2179-2017Don't want to check this manually?
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