The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.
Reported: July 19, 2017 Initiated: March 10, 2016 #Z-2707-2017
Product Description
The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.
Reason for Recall
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.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 555 PDM's
- Distribution
- Distribution US nationwide.
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.. Recalled by Merge Healthcare, Inc.. Units affected: 555 PDM's.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 19, 2017. Severity: Moderate. Recall number: Z-2707-2017.
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