FDA-Device2019-07-31Class II
Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
Spacelabs Healthcare, Inc.
Hazard
Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.
Sold states
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.
Affected count
295 customer sites have the affected software versions
Manufactured in
35301 Se Center St, N/A, Snoqualmie, WA, United States
Products
Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2035-2019Don't want to check this manually?
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