FDA-Device2017-02-22Class II
The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.
Merge Healthcare, Inc.
Hazard
Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure.
Sold states
Distribution was nationwide to medical facilities. There was also military and government distribution.
Affected count
341 sites potentially have the affected product versions
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1203-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief