Reported Nov 27, 2013 · Terminated
Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or…
Spacelabs Healthcare, LLC
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, Llc · 35301 Se Center St · Snoqualmie, WA · 98065-9216
Is this the product you have?
- Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications.
- Lot codes and dates
- SERIAL NUMBERS IN THE US
1390-1019401390-1019451390-1019461390-1019471390-1019481390-1019501390-1019511390-1019521390-1019531390-1019541390-1019551390-1019561390-1019571390-1019581390-1019621390-1019631390-1019711390-1019721390-1019731390-1019741390-1019791390-1019801390-1019941390-1020021390-1020031390-1020041390-1020051390-1020061390-1020071390-1020081390-1020091390-1020101390-1020111390-1020121390-1020131390-1020141390-1020151390-1020161390-1020171390-1020181390-102019and 1390-102020
- SERIAL NUMBER INTERNATIONAL
1390-1019491390-1019691390-1019701390-1019751390-1019761390-1019771390-1019781390-1020011390-1020211390-1020221390-102023and 1390-102024
- SERIAL NUMBERS IN THE US
- Amount recalled
- 54 units total (42 units in the US and 12 outside US)
Where it was sold
Why it was recalled
Spacelabs Healthcare qube Compact Patient Monitor, Model 91390, may fail to power ON due to incorrect programmed microcontroller component.
This product could cause temporary or reversible health problems — stop using it.
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