Spacelabs Healthcare, Inc. recalls Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.

Recall date

January 28, 2019

Source

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

Recall number

Z-2035-2019

FDA classification

Class II

Brand / firm

Spacelabs Healthcare, Inc.

Sold / distributed

Distribution was nationwide. There was also government and military distribution. Foreign distribution was made to Argentina, Bahrain, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Costa Rica, Czech Republic, France, Hong Kong, India, Indonesia, Italy, Kuwait, Malaysia, Mexico, Netherlands…

Why it was recalled

Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.

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

What was recalled

Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.