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.
- Company
- Respironics, Inc.
- Recall Initiated
- April 23, 2009
- Posted
- May 19, 2009
- Terminated
- October 19, 2011
- Recall Number
- Z-1411-2009
- Quantity
- 4,992 units
- Firm Location
- Murrysville, PA
Reason for Recall
Audible alarm failure.
Distribution
Nationwide and Canada.
Lot / Code Info
Model Number 4002; Serial Numbers 3000033364 through 3000038740 and Model Number 4003; Serial Numbers 3000033364 through 3000038740.
Root Cause
Process design
Action Taken
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 about the recall, contact Stericycle Customer Service by calling at 888-345-4630.