Medley Pca Module, Model 8120

• • Ongoing Z-2882-2020 FDA Class I ·initiated 4 Aug 2020 ·via K043299, on the same 510(k)

  The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in delays in infusion, under-infusion, or over-infusion.

• • Terminated Z-1712-2008 FDA Unclassified (pre-2012) ·initiated 5 Mar 2008 ·via K043299, on the same 510(k)

  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 ·via K043299, on the same 510(k)

  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

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

510(k) Number

K043299 ↗

FDA Product Code

MEA

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

• Medley Syringe Pump Module System, Model 8110 Open recall

  Class II

  FDA 510(k) K023264 Active Cleared 19 Dec 2002

• 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

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