Merge Healthcare Recalls Schiller PB 1000 Patient Data Module
Merge Healthcare is recalling 555 Schiller PB 1000 Patient Data Modules because the analog output may not accurately reflect the pressure waveform used for fractional flow reserve calculations.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that could lead to inaccurate clinical calculations (FFR), representing a risk of harm where specific injury reports are not detailed in the source text.
Plain-English summary
Merge Healthcare, Inc. is recalling 555 units of the Schiller PB 1000, also known as the Merge Hemo Patient Data Module (PDM). This device is a major component of the Merge Hemo software. The recall covers all Schiller PB-1000 PDMs distributed in the United States on or before August 11, 2016.
The recall was initiated because the analog output of the PDM may not accurately reflect the true representation of the selected pressure waveform. This inaccuracy occurs when the PDM is utilized to output a pressure for computing fractional flow reserve (FFR). The PDM provides this analog output to the Link Assembly.
Healthcare facilities and users of the Merge Hemo software should stop using the affected PDMs for FFR calculations. Users should contact Merge Healthcare for instructions on how to proceed with the recall.
The recalled product
- Product
- The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.
- Manufacturer
- Merge Healthcare, Inc.
- Affected units
- 555
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Schiller PB-1000 PDM's distributed on or before 8/11/2016.
Distribution
Distributed nationwide across the United States.
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