Recall Z-1411-2009 ยท FLS Monitor, Apnea, Facility Use
Respironics, Inc.
SmartMonitor 2 Infant Apnea Monitor. The monitor is intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor detects and alarms for periods of central apnea and high or low heart rates.
| Date | May 19, 2009 (initiated Apr 23, 2009) |
| Status | Terminated |
| Reason | Audible alarm failure. |
| Root cause | Process design |
| Action | A notification letter dated April 23, 2009 was issued to consignees informing them of the issue. Consignees were instructed to locate the affected units in their inventory and return them to Philips Children's Medical Ventures-Youngwood Service. Any units that were shipped by consignees to their customers are to be retrieved and returned to Respironics. Consignees were also instructed to complete the enclosed Business Reply Form and Serial Number Reconciliation List and fax to Stericycle at 888-345-5369 or email to respironics1985@stericycle.com. For questions and additional information ab |
| Quantity | 4,992 units |
| Distribution | Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011597 | SMARTMONITOR 2, MODEL 4000 Respironics Georgia, Inc., Jan 11, 2002 |