The Schiller PB 1000 — Class II medical device recall Z-2707-2017
Terminated recall by Merge Healthcare, Inc., reported 2017-07-19, distributed nationwide. If the PDM is utilized to output a pressure for computing fractional flow reserve (FFR), the analog output may
| Recall number | Z-2707-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2016-03-10 |
| Classified | 2017-07-10 |
| Reported by FDA | 2017-07-19 |
| Terminated | 2020-03-06 |
| Distributed | Nationwide (US) |
| Quantity | 555 pdm |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2707-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.