Reported Jul 23, 2014 · Terminated
Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a…
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 Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits.
- Lot codes and dates
- Serial Numbers
2518-0001832518-0001842518-0001852518-0001862518-0002062518-0002072518-0002082518-000209
- Serial Numbers
- Amount recalled
- 8 units total (3 units in US)
Where it was sold
Why it was recalled
With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.
This product could cause temporary or reversible health problems — stop using it.
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