Reported Feb 22, 2017 · Terminated
The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge…
Merge 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: Merge Healthcare, Inc. · 900 Walnut Ridge Dr · Hartland, WI · 53029-8347
Is this the product you have?
- The Schiller PB 1000
- also known asMerge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software
- Lot codes and dates
- Patient Data Module (PDM) V2 modelSerial numbers 10.03.XXXXX
- Amount recalled
- 341 sites potentially have the affected product versions
Where it was sold
- Nationwide
Why it was recalled
Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure.
This product could cause temporary or reversible health problems — stop using it.
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