Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adul
FDA device recall Z-2283-2010 · posted 2010-08-26 · Terminated
Recall details
- Recalling firm
- Draeger Medical Systems, Inc.
- Reason for recall
- Monitor keys may become inoperative or activate spontaneously, causing a membrane switch panel malfunction. This may discharge a patient automatically.
- Action taken
- Draeger Medical issued "Urgent-Medical Device Recall Notification" letters to affected consignees. The Delta/Gamma X XL monitor keyboards will be updated with new material at each affected facility. If the keys on affected monitors become inoperative or activate without user interaction, the customer is instructed to remove the monitor from service and contact Draeger at 978-379-8573. A Technical Service Bulletin (TSB) will be distributed globally, instructing subsidiaries to inform international customers.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 8675 units
- Distribution
- Worldwide Distribution - United States, including the states of AL, AR, CA, CO, DC, FL, GA, IA, IL, IN, KS, LA, MA, ME, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA,
- Date initiated
- 2010-06-04
- Date posted
- 2010-08-26
- Date terminated
- 2012-07-30
- Location
- Telford, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL (K070566) | Draeger Medical Systems, Inc. | 2007-06-04 |