The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.
Reported: February 22, 2017 Initiated: May 31, 2015 #Z-1203-2017
Product Description
The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.
Reason for Recall
Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 341 sites potentially have the affected product versions
- Distribution
- Distribution was nationwide to medical facilities. There was also military and government distribution.
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.. Recalled by Merge Healthcare, Inc.. Units affected: 341 sites potentially have the affected product versions.
Why was this product recalled? ▼
Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 22, 2017. Severity: Moderate. Recall number: Z-1203-2017.
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