Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0361-2017 — Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16026. Note that Hospira retired this pump June 30, 2015. The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blo

U.S. FDA — Device Enforcement · United States · 2011-03-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0361-2017
Date of alert
2011-03-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Hospira Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
14339017
Reported risk: May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device. The infusion and the processor stop, sound a 3 minute audible alarm from the backup buzzer and deactivate the couch screen and the automated loading/unloading of cassettes. Delay or interruption of therapy.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.