FDA Device recall Z-2707-2017
The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software
- FDA Device
- Class II
- terminated
- Published 2017-07-19
On 2017-07-19 the FDA classified a Class II recall of The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software by Merge Healthcare, citing 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 wavefor….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2707-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-10 |
| Published | 2017-07-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merge Healthcare |
| Distribution | US |
Product
The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.
Reason
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.
Identifiers
| code_info | All Schiller PB-1000 PDM's distributed on or before 8/11/2016. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Merge Healthcare
- Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
FDA Device · Class II · 2026-09-02 · Merge Healthcare - Merge PACS, medical imaging diagnostic workstation
FDA Device · Class II · 2026-08-12 · Merge Healthcare - Merge OrthoPACS, medical imaging diagnostic workstation
FDA Device · Class II · 2026-08-12 · Merge Healthcare - Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCS…
FDA Device · Class II · 2025-09-10 · Merge Healthcare - Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2
FDA Device · Class II · 2025-03-26 · Merge Healthcare
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2707-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.