Infinity Docking Station (IDS) Delta and Kappa Series patient Monitors. Model numbers 4715319, 5206110, 5732388, and 748
FDA device recall Z-0301-2007 · posted 2006-12-19 · Terminated
Recall details
- Recalling firm
- Draeger Medical, Inc.
- Reason for recall
- Top cover of assembly may separate. The situation can result in the monitor falling, which could result in an injury to the clinician or patient.
- Action taken
- The recaling firm issued a recall letter to the US customers 11/17/2006 via certified mail. An authorized service representative will inspect each potentially affected unit. If a unit is found to have an affected docking station, the unit will be repaired or replaced free or charge. Notification to international customers will occur through the international subsidiaries.
- Root cause
- Other
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 23,345 units - 4336 US
- Distribution
- Nationwide
- Date initiated
- 2006-11-17
- Date posted
- 2006-12-19
- Date terminated
- 2008-11-19
- Location
- Telford, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS (K060039) | Draeger Medical Systems, Inc. | 2006-04-12 |