FDA Medical Device Recalls (openFDA)
Hospira Inc: 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.
- Recall number
- Z-1815-2009
- Recalling firm
- Hospira Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2009-03-31
- Posted
- 2009-08-11
- Terminated
- 2010-12-18
- Reason
- Potential delay/underinfusion of critical therapy-- Devices experience increased frequency of alarms that result in temporary pump stoppage.
- 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.
- Quantity
- not on file
- Distribution
- Product was distributed to 59 consignees to all 50 States.
- Lot, serial or model codes
- List number 16026-04-83/84 and 87/88, software versions 2.1 and 3.0 only.
- 510(k) numbers
- ["K041550"]
- PMA numbers
- not on file
- Product code
- frn
- Firm FEI
- 2921482
- Firm city
- Morgan Hill
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28