FDA-Device2017-07-19Class II
The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.
Merge Healthcare, Inc.
Hazard
If the PDM is utilized to output a pressure for computing fractional flow reserve (FFR), the analog output may not reflect the true representation of the selected pressure waveform being provided by the PDM to the Link Assembly which provides the analog output.
Sold states
Distribution US nationwide.
Affected count
555 PDM's
Manufactured in
900 Walnut Ridge Dr, Hartland, WI, United States
Products
The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2707-2017Don't want to check this manually?
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