Recall Z-1923-2017 ยท DQK Computer, Diagnostic, Programmable
Merge Healthcare, Inc.
Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a major component of the Merge Hemo system.
| Date | May 2, 2017 (initiated Mar 30, 2015) |
| Status | Terminated |
| Reason | The units may display the alarm "sampling line clogged" after the flow zeroing procedure that is conducted automatically 1 hour after start up. This could result in the potential of a small bias added to the CO2 measurement and affect the alarm notification. |
| Root cause | Unknown/Undetermined by firm |
| Action | The recall was initiated by telephone on March 30, 2015. Follow-up phone calls were made July 6, 2015. The firm was unable to provide a telephone script. The recalling firm also issued letters dated March 28, 2016, via email on April 6, 2016, dated July 11, 2016. The letters contained the same content, notified the customer of the issue, and informed them a fix was available. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is req |
| Quantity | 23 sensors (PhaseIn Units) |
| Distribution | US Distribution was made to medical facilities located in AL, FL, ID, LA, MO, NC, OK, SC, TX, and UT. There was government distribution and no foreign/military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082421 | HEARTSUITE HEMODYNAMICS 7.10 Emageon, Inc., Dec 17, 2008 |