SmartMonitor 2 Infant Apnea Monitor. The monitor is intended for use in the continuous monitoring of respiration and hea
FDA device recall Z-1411-2009 · posted 2009-05-19 · Terminated
Recall details
- Recalling firm
- Respironics, Inc.
- Reason for recall
- Audible alarm failure.
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- FLS
- Quantity affected
- 4,992 units
- Distribution
- Nationwide and Canada.
- Date initiated
- 2009-04-23
- Date posted
- 2009-05-19
- Date terminated
- 2011-10-19
- Location
- Murrysville, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SMARTMONITOR 2, MODEL 4000 (K011597) | Respironics Georgia, Inc. | 2002-01-11 |