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Spacelabs Healthcare, Inc. recalls Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
Recalled July 31, 2019 · FDA recall Z-2035-2019 · Spacelabs Healthcare
Hazard
Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms. · FDA Class II
Units
295 customer sites have the affected software versions
Sold at
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, Pakistan, Palestine, Panama, Philippines, Poland, Qatar, Romania, Saudi Arabia, Spain, Switzerland, Taiwan, Trinidad and Tobago, Tunisia, Turkey, UAE, United Kingdom, and Viet Nam.
Description
Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.
Product
Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
Manufacturer(s)
Spacelabs Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →