Medley Syringe Pump Module System, Model 8110

• • Ongoing Z-1645-2026 FDA Class II ·initiated 11 Feb 2026

  Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units

• • Terminated Z-0322-2018 FDA Class II ·initiated 17 Nov 2017

  The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.

• • Terminated Z-2879-2016 FDA Class II ·initiated 8 Aug 2016

  A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to unexpectedly stop when the Syringe module is transitioning from one rate to another.

• • Terminated Z-2362-2015 FDA Class I ·initiated 21 Jul 2015

  Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syringe module. After the error is cleared on the PCU, the syringe pump is unresponsive to key presses until the next power cycle, or the module is detached and reattached.

• • Terminated Z-1794-2009 FDA Unclassified (pre-2012) ·initiated 12 Jun 2009

  There is a potential risk of IUI connector failure in the Alaris System when these connectors become corroded or contaminated, which may result in an interruption of infusion with an audible and visual alarm. IUI connectors can become corroded or contaminated when exposed to fluid spills or improper cleaning. This notification is to reinforce the importance of inspection of IUI connectors prior

• • Terminated Z-1712-2008 FDA Unclassified (pre-2012) ·initiated 5 Mar 2008

  A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors due to failure of the U9 Socketed Integrated Circuits (U9 IC) on the display board of the Alaris Syringe Module ("Syringe module") and Alaris PCA module ("PCA module") for modules manufactured on or before October 4, 2005. The user will be required to re

• • Terminated Z-1711-2008 FDA Unclassified (pre-2012) ·initiated 5 Mar 2008

  A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors with the Alaris System due to the Inter-Unit Interface (IUI) connectors on all Alaris System modules (manufactured on or before March 26, 2004). Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built on or before March

510(k) Number

K023264 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Variable Pressure Syringe Pump

  Class II

  FDA 510(k) K974332 Active Cleared 29 Dec 1998

• A-Line Aep Monitor

  Class II

  FDA 510(k) K010965 Active Cleared 27 Jun 2001

• Medley ETCO2 Module (Includes Accessories), Model 8300

  Class II

  FDA 510(k) K031741 Active Cleared 9 Feb 2004

• Medley SPO2 Module, Model 8210 & SPO2 Sensors & Cable

  Class II

  FDA 510(k) K022677 Active Cleared 11 Sep 2002

• Alaris Medical Infusion System Administration Sets Open recall

  Class II

  FDA 510(k) K022209 Active Cleared 6 Aug 2002

• Medley Pca Module, Model 8120 Open recall

  Class II

  FDA 510(k) K043299 Active Cleared 10 Dec 2004

See all devices from Alaris Medical Systems, Inc. →