FDAFDA · Food and drugs·Recall number Z-1203-2017
The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.
Published February 22, 2017 · Recall initiated: May 31, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure.
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- Merge Healthcare, Inc.
- Distributor
- Distribution was nationwide to medical facilities. There was also military and government distribution.
- Lot
- Patient Data Module (PDM) V2 model: Serial numbers 10.03.XXXXX
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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