Recall Z-2250-2017 ยท NPE Material, Embolization, Neurovascular, Polymerizing Or Precipitating
Circadiance LLC
SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.
| Date | May 1, 2017 |
| Status | Terminated |
| Reason | Circadiance has determined that it is possible for certain Smart Monitor 2PS/PSL monitors to exhibit intermittent operation of the nurse call feature. The firm has updated the device to increase the "Nurse Call" feature to ensure monitor alarms are transmitted to compatible nurse call systems. |
| Root cause | Under Investigation by firm |
| Action | Circadiance mailed a Medical Device Removal SmartMonitor 2 PS/PSL, dated 04/28/2017, to affected customers to inform them of the issue, the actions to be taken and the actions the firm plans to take to correct the issue. Customers are told to test the functionality of the system prior to each use; and, complete the Business Reply Form. The form can be returned via 412-202-4583 or emailed to james.gianoutsos@circadiance.com. Customers are to contact Circadiance Customer Service at 724-858-2837 to receive an Return Material Authorization number; or, 1-888-825-9640 to repair their unit free o |
| Quantity | 1,242 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061256 | SMARTMONITOR 2PS Respironics, Inc., Aug 2, 2006 |