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Merge Healthcare, Inc. recalls The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo
Recalled February 22, 2017 · FDA recall Z-1203-2017 · Merge Healthcare
Hazard
Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure. · FDA Class II
Units
341 sites potentially have the affected product versions
Sold at
Distribution was nationwide to medical facilities. There was also military and government distribution.
Description
Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure.
Product
The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.
Manufacturer(s)
Merge Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →