SmartMonitor 2 Infant Apnea Monitor recallZ-1411-2009 · Respironics, Inc. · initiated Apr 23, 2009
Terminated All recalls posted in May 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Respironics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Audible alarm failure.
FDA root cause category: Process design
What the company is doing
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.
Recall details
- Recall number
- Z-1411-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 23, 2009
- Posted by the FDA
- May 19, 2009
- Recalling firm
- Respironics, Inc.
- Quantity
- 4,992 units
- Product code
- FLS
- FDA submissions
- K011597
- Distribution
- Nationwide and Canada.
Product description
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.
Code information (models, lots, serial numbers)
Model Number 4002; Serial Numbers 3000033364 through 3000038740 and Model Number 4003; Serial Numbers 3000033364 through 3000038740.
Other devices under the same FDA submission
2 devices cleared under K011597 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SmartMonitor 2 w/o Modem 4002Circadiance, LLC · Monitor, Apnea, Facility Use5 reports
- SmartMonitor 2 w/ Modem 4003Circadiance, LLC · Monitor, Apnea, Facility Use4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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