Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1816-2009

Hospira Phoenix Infusion System with MedNet Software, Symbiq Two-Channel Infusion System, Software versions...

Abbott Medical / initiated 2009-03-31 / Terminated / root cause: software

Hospira Inc began a recall of Hospira Phoenix Infusion System with MedNet Software, Symbiq Two-Channel Infusion System, Software versions v2.1 & v3.0, Manufactured by Hospira Inc., Morgan... on . The reason FDA records is "Potential delay/underinfusion of critical therapy-- Devices experience increased frequency of alarms that result in temporary pump stoppage". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-1816-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Abbott Medical
Product
Hospira Phoenix Infusion System with MedNet Software, Symbiq Two-Channel Infusion System, Software versions v2.1 & v3.0, Manufactured by Hospira Inc., Morgan Hill, CA
Product code
frn
Reason for recall
Potential delay/underinfusion of critical therapy-- Devices experience increased frequency of alarms that result in temporary pump stoppage.
Root cause tag
software
FDA root cause
Software design
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.
Distribution
Product was distributed to 59 consignees to all 50 States.
Product codes and lots
List number 16027-04-83/84 and 87/88, software versions 2.1 and 3.0 only.