Hospira Phoenix Infusion System with MedNet Software, Symbiq One-Channel Infusion System, Software versions v2.1 & v3.0, Manufactured by Hospira Inc., Morgan Hill, CA.
FDA Recall Z-1815-2009 · Posted 2009-08-11
Recalling FirmHospira Inc
Recall StatusTerminated
Product Codefrn
Date Initiated2009-03-31
Date Terminated2010-12-18
Reason for Recall
Potential delay/underinfusion of critical therapy-- Devices experience increased frequency of alarms that result in temporary pump stoppage.
Firm Action
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
Distribution Pattern
Product was distributed to 59 consignees to all 50 States.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.