Recall Z-1203-2017 ยท DQK Computer, Diagnostic, Programmable
Merge Healthcare, Inc.
The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.
| Date | May 31, 2015 |
| Status | Terminated |
| Reason | Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure. |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm issued letters via email dated 3/28/2016 and 7/11/2016, or via certified mail if no email address was available. A third letter dated 1/23/2017 was also issued.. |
| Quantity | 341 sites potentially have the affected product versions |
| Distribution | Distribution was nationwide to medical facilities. There was also military and government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082421 | HEARTSUITE HEMODYNAMICS 7.10 Emageon, Inc., Dec 17, 2008 |