Reported Aug 10, 2016 · Terminated
91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 &…
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?
- 91496 Ultraview SL Command Module, Options A, B, C, and I
- Option A
ECG/RespirationSpO2Temperature x2 & adult/neonate NIBP
- Option B
ECG/RespirationInvasive Pressure x2SpO2Temperature x2 & adult/neonate NIBP
- Option C
ECG/RespirationInvasive Pressure x4SpO2Cardiac OutputTemperature x2 & adult/neonate NIBP
- Option I
SpO2Temperature x2& adult/neonate NIBP
- Lot codes and dates
- Manifold Lot Codes
128280129420129940or 155640
- Manifold Lot Codes
- Amount recalled
- 3801 modules and 116 PCBAs & valves distributed in the US; 1297 modules and 366 PCBAs & valves distributed outside the US
Why it was recalled
The firm has received multiple reports of the Non-Invasive Blood Pressure (NIBP) parameter becoming non-functional with an associated message (No Reading). In addition, there is one of the following three error messages: Inflate Error, HW Error, or No Data.
This product could cause temporary or reversible health problems — stop using it.
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