# FDA recall Z-2707-2017

> **Merge Healthcare, Inc.** · Class II · device recall initiated 2016-03-10.

## Product

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.

## Distribution

Distribution US nationwide.

## Key facts

- **Recall number:** Z-2707-2017
- **Recalling firm:** Merge Healthcare, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-03-10
- **Report date:** 2017-07-19
- **Termination date:** 2020-03-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hartland, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2707-2017

## Citation

> AI Analytics. FDA recall Z-2707-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2707-2017. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*