Merge Healthcare Recalls Schiller PB 1000 Blood Pressure Pumps
Merge Healthcare is recalling Schiller PB 1000 blood pressure pumps because insufficient voltage causes them to fail before reaching adequate pressure.
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 is classified as FDA Class II, and the hazard involves a medical device failure that could prevent adequate blood pressure measurement, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Merge Healthcare, Inc. is recalling the Schiller PB 1000, also known as the Merge Hemo Patient Data Module (PDM) V2 model. This device is a major component of the Merge Hemo software used in medical facilities.
The recall is due to a defect where the non-invasive blood pressure (NIBP) pumps have insufficient voltage. This issue causes the pumps to fail prior to reaching adequate initial pressure. The affected units are identified by serial numbers 10.03.XXXXX.
Distribution was nationwide to medical facilities, as well as to military and government entities. Approximately 341 sites potentially have the affected product versions. Users should contact Merge Healthcare for instructions on how to address the defect.
The recalled product
- Product
- The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.
- Manufacturer
- Merge Healthcare, Inc.
- Affected units
- 341
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)
- Patient Data Module (PDM) V2 model: Serial numbers 10.03.XXXXX
Distribution
Distributed nationwide across the United States.
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