Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Spacelabs Healthcare Smart Disclosure System Recalled by Spacelabs Healthcare, Inc. Due to Several reports were received that patient records were...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Spacelabs Healthcare, Inc. directly.
Affected Products
Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
Quantity: 295 customer sites have the affected software versions
Why Was This Recalled?
Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Spacelabs Healthcare, Inc.
Spacelabs Healthcare, Inc. has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report