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Recall Observatory FDA recall evidence

Device product

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

Z-2035-2019

January 28, 2019

Class II

Product summary

Firm
Spacelabs Healthcare, Inc.
Event
Event 83220
Status
Terminated
Classification
Class II
Quantity
295 customer sites have the affected software versions
Official record key
device-enforcement:Z-2035-2019

Official wording

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

Code information: All affected Smart Disclosure installations with software versions 5.00, 5.01, 5.02, or 5.03, UDI 10841522123580.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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