Reported Jul 31, 2019 · Terminated
Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
Spacelabs Healthcare, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spacelabs Healthcare, Inc. · 35301 Se Center St · Snoqualmie, WA · 98065-9216
Is this the product you have?
- Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
- Lot codes and dates
- All affected Smart Disclosure installations with software versions 5.00, 5.01, 5.02, or 5.03, UDI 10841522123580.
- Amount recalled
- 295 customer sites have the affected software versions
Where it was sold
- Nationwide
Why it was recalled
Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.
This product could cause temporary or reversible health problems — stop using it.
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