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Hospira Phoenix Infusion System with Hospira Mednet Software

by Abbott Laboratories 510(k)

Active United States

510(k) K041550

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK041550 Date30 Jun 2004ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
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  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

36 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2056-2016 FDA Class II initiated 4 Feb 2013
    • Terminated Z-2055-2016 FDA Class II initiated 4 Feb 2013

    Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and 16027. When there are false alarms, the pump will continue to alarm even though there is no occlusion present. False POAs could result in a delay/interruption in therapy, and require the clinician to reset the alarm multiple times or to replace the pump.

  • 2 recalls, same reason

    • Terminated Z-0069-2013 FDA Class I initiated 29 Aug 2012
    • Terminated Z-0070-2013 FDA Class I initiated 29 Aug 2012

    The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user. Failure of the touchscreen to respond to user input could result in a delay in therapy or result in over delivery or under delivery of medication if the user does not confirm the programmed values on the pump's confirmation screen prior to starting the infusion.

  • 2 recalls, same reason

    • Terminated Z-0362-2017 FDA Class II initiated 16 Mar 2011
    • Terminated Z-0361-2017 FDA Class II initiated 16 Mar 2011

    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.

  • 2 recalls, same reason

    • Terminated Z-1895-2010 FDA Unclassified (pre-2012) initiated 9 Apr 2010
    • Terminated Z-1894-2010 FDA Unclassified (pre-2012) initiated 9 Apr 2010

    Hospira has received numerous customer complaints of the Symbiq infusion pump's failure to detect air-in-line conditions during operation.

    • Terminated Z-2381-2010 FDA Unclassified (pre-2012) initiated 26 Mar 2010

    If the administrator set is removed prior to the cassette carriage fully opening without closing the slide/roller clamp, unrestricted flow and delivery may result.

  • 2 recalls, same reason

    • Terminated Z-2390-2010 FDA Unclassified (pre-2012) initiated 22 Feb 2010
    • Terminated Z-2391-2010 FDA Unclassified (pre-2012) initiated 22 Feb 2010

    The clamp may not secure to the IV pole and the pump may slip or fall off. The pump may fall on a person or pull the tubing out of the IV container.

  • 2 recalls, same reason

    • Terminated Z-0127-2011 FDA Unclassified (pre-2012) initiated 22 Feb 2010
    • Terminated Z-0128-2011 FDA Unclassified (pre-2012) initiated 22 Feb 2010

    Hospira has identified motor encoder failures in the Symbiq pumping mechanism that causes the infuser to cease operation during infusion therapy, resulting in delay or interruption of infusion therapy.

    • Terminated Z-0808-2010 FDA Unclassified (pre-2012) initiated 8 Jan 2010 via K041550, on the same 510(k)

    There is a potential for fluid to leak from the backcheck valve which could result in inaccurate delivery and occupational exposure.

  • 19 recalls, same reason

    • Terminated Z-1061-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 via K041550, on the same 510(k)
    • Terminated Z-1058-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 via K041550, on the same 510(k)
    • Terminated Z-1059-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 via K041550, on the same 510(k)
    • Terminated Z-1057-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 via K041550, on the same 510(k)
    • Terminated Z-1062-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 via K041550, on the same 510(k)
    • Terminated Z-1051-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 via K041550, on the same 510(k)
    • Terminated Z-1045-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 via K041550, on the same 510(k)
    • Terminated Z-1060-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 via K041550, on the same 510(k)
    • Terminated Z-1053-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 via K041550, on the same 510(k)
    • Terminated Z-1047-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 via K041550, on the same 510(k)
    • Terminated Z-1049-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 via K041550, on the same 510(k)
    • Terminated Z-1046-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 via K041550, on the same 510(k)
    • Terminated Z-1052-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 via K041550, on the same 510(k)
    • Terminated Z-1048-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 via K041550, on the same 510(k)
    • Terminated Z-1050-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 via K041550, on the same 510(k)
    • Terminated Z-1054-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 via K041550, on the same 510(k)
    • Terminated Z-1063-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 via K041550, on the same 510(k)
    • Terminated Z-1056-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 via K041550, on the same 510(k)
    • Terminated Z-1055-2010 FDA Unclassified (pre-2012) initiated 24 Nov 2009 via K041550, on the same 510(k)

    Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.

  • 2 recalls, same reason

    • Terminated Z-1815-2009 FDA Unclassified (pre-2012) initiated 31 Mar 2009
    • Terminated Z-1816-2009 FDA Unclassified (pre-2012) initiated 31 Mar 2009

    Potential delay/underinfusion of critical therapy-- Devices experience increased frequency of alarms that result in temporary pump stoppage.

    • Terminated Z-0944-2009 FDA Unclassified (pre-2012) initiated 3 Dec 2008

    Hypersensitivity to normal motor friction/drag may cause malfunction errors and alarms that are designed to stop pump operations.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
FRN
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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