FDAFDA · Food and drugs·Recall number Z-2707-2017
The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.
Published July 19, 2017 · Recall initiated: March 10, 2016
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
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Merge Healthcare, Inc.
- Distributor
- Distribution US nationwide.
- Lot
- All Schiller PB-1000 PDM's distributed on or before 8/11/2016.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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