Recall Z-2641-2017 ยท DQA Oximeter
Merge Healthcare, Inc.
Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting E
| Date | Apr 4, 2016 |
| Status | Terminated |
| Reason | Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care. |
| Root cause | Component change control |
| Action | Merge sent an Urgent: Medical Device Recall letter dated March 28, 2016 via e-mail the week of 4/4/2016. If no email address was available, the letters were issued via certified mail. A second letter dated July 11, 2016 was issued to non-responders. The letter identified the affected product problem and actions to be taken. |
| Quantity | 2 sensors |
| Distribution | Distribution was nationwide. There was also government and military distribution. There was no foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051212 | MODIFICATION TO LNCS OXIMETRY SENSORS Masimo Corporation, Jul 12, 2005 |