Z-1411-2009

SmartMonitor 2 Infant Apnea Monitor. The monitor is intended for use in the continuous monitoring of...

Name: Z-1411-2009 SmartMonitor 2 Infant Apnea Monitor. The monitor is intended for use in the continuous monitoring of...
Creator: Respironics, Inc.
Published: 2009-04-23
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2009-04-23 / Terminated / root cause: manufacturing process

FDA source

Respironics, Inc. began a recall of 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... on 2009-04-23. The reason FDA records is "Audible alarm failure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1411-2009
Status: Terminated
Initiated: 2009-04-23
Posted: 2009-05-19
Terminated: 2011-10-19
Recalling firm: Respironics, Inc.
Product: 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.
Product code: FLS Monitor, Apnea, Facility Use
Reason for recall: Audible alarm failure.
Root cause tag: manufacturing process
FDA 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 [email protected]. For questions and additional information about the recall, contact Stericycle Customer Service by calling at 888-345-4630.
Quantity in commerce: 4,992 units
Distribution: Nationwide and Canada.
Product codes and lots: Model Number 4002; Serial Numbers 3000033364 through 3000038740 and Model Number 4003; Serial Numbers 3000033364 through 3000038740.

Product code FLS

K011597Class IISmartmonitor 2, Model 4000Respironics Georgia, Inc. / cleared 2002-01-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)