Hospira Symbiq Infusion Pump Recalled for White Screen Shutdown
Hospira is recalling 10,337 Symbiq One Channel Infusers because a software issue may cause a white screen, stopping infusion and interrupting therapy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves the interruption of medical therapy, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Hospira Inc. is recalling 10,337 units of the Symbiq One Channel Infuser, a prescription medical device used to administer intravenous fluids. The recall affects devices distributed in the United States and Canada. The Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via various routes of administration.
The recall is due to a problem with the SOM2 module that may cause the device to display a white screen. This white screen is a diagnostic screen shown as part of the safety shutdown procedure. When this occurs, the infusion and processor stop, a three-minute audible alarm sounds from the backup buzzer, and the device deactivates the touch screen and the automated loading and unloading of cassettes.
The primary hazard associated with this defect is the delay or interruption of therapy. Hospira retired this pump on June 30, 2015. Users should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected.
The recalled product
- Product
- 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, nutritional
- Manufacturer
- Hospira Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 10,337
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Hospira Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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