Recall Z-2707-2017 ยท DQK Computer, Diagnostic, Programmable
Merge Healthcare, Inc.
The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.
| Date | Mar 10, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | The recalling firm issued recall letters dated 3/10/2016, 5/3/2016, and 8/5/2016 via email or via certified mail if the email address is not available. |
| Quantity | 555 PDM's |
| Distribution | Distribution US nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082421 | HEARTSUITE HEMODYNAMICS 7.10 Emageon, Inc., Dec 17, 2008 |