Hospira Phoenix Infusion System with MedNet Software, Symbiq Two-Channel Infusion System, Software versions v2.1 & v3.0,
FDA device recall Z-1816-2009 · posted 2009-08-11 · Terminated
Recall details
- Recalling firm
- Hospira Inc
- Reason for recall
- Potential delay/underinfusion of critical therapy-- Devices experience increased frequency of alarms that result in temporary pump stoppage.
- Action taken
- Hospira, Inc. issued an "Urgent: Device Field Correction" dated March 31, 2009 via Federal Express to Healthcare Professionals and Valued Hospira Customers. Consignees were informed of the affected devices and will be contacted by a Hospira representative to arrange necessary device upgrades. For further questions, contact Hospira Global Product Safety and Complaints at 1-800-441-4100.
- Root cause
- Software design
- Status
- Terminated
- Product code
- frn
- Distribution
- Product was distributed to 59 consignees to all 50 States.
- Date initiated
- 2009-03-31
- Date posted
- 2009-08-11
- Date terminated
- 2010-12-18
- Location
- Morgan Hill, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE (K041550) | Abbott Laboratories | 2004-06-30 |