Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Schiller PB 1000 Recalled by Merge Healthcare, Inc. Due to If the PDM is utilized to output a...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Merge Healthcare, Inc. directly.
Affected Products
The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.
Quantity: 555 PDM's
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Merge Healthcare, Inc.
Merge Healthcare, Inc. has 93 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report