GE Healthcare, LLC recalls Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems

Recall date

February 6, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2179-2017

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

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,…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems