# K051641: Alaris System PC Unit, Model 8001

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health, Alaris Products
- Decided: Oct 20, 2005 after 122 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 26 (10 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K950419 (1995). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
4 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950419: The Imed Orion Infusion Pump and Administration Sets, Imed Corp. (1995) Summary page 2.

## Most influential descendants
- K091308: Alaris PC Unit, Models 8000 and 8015 (2009), 5 descendants of its own
- K133532: Alaris System with Guardrails Suite MX (2014), 3 descendants of its own
- K211218: BD Alaris System with Guardrails Suite MX v12.1.2 (2023), 1 descendant of its own
- K243855: BD Alaris Infusion System with Guardrails Suite MX (2025), 0 descendants of its own
- K210074: Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable (2022), 0 descendants of its own

## Recalls of this device
- Feb 11, 2026 · Class II · Z-1645-2026: 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
- Sep 15, 2023 · Class I · Z-0185-2024: Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
- Sep 15, 2023 · Class I · Z-0184-2024: Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
- Sep 15, 2023 · Class I · Z-0186-2024: Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
- Feb 4, 2020 · Class I · Z-1360-2020: 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 
- Feb 4, 2020 · Class I · Z-1362-2020: 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 
- Feb 4, 2020 · Class I · Z-1361-2020: 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 
- Jun 12, 2017 · Class II · Z-2671-2017: BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error Code 255-16-275 and can potentially result in interrup
- Nov 1, 2016 · Class II · Z-1520-2017: Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion channels are stopped.
- May 12, 2016 · Class II · Z-2064-2016: A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module mod
- Mar 24, 2016 · Class II · Z-1606-2016: The Alaris PC units model 8015 may display a system error code 133.6080 due to failure with the super capacitor (C245) at power up on the Alaris PC unit logic boards.
- Feb 12, 2016 · Class II · Z-1239-2016: CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may cause a "System Error" or "Missing Battery" error code (120.4630).
- May 13, 2015 · Class II · Z-1811-2015: An issue with the cancel functionality used during atypical infusion programming to cancel user inputted values. An infusion may start that is greater than or less than the hospital established limits
- Mar 12, 2015 · Class II · Z-1311-2015: CareFusion is recalling the Alaris PC unit because of an error code. The error code may occur upon power on during the "Power-On Self Test" due to a keypad issue.
- Dec 5, 2013 · Class I · Z-0534-2014: CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will produce an audible alarm and the Alaris PC unit will display a System Error message.
- Jun 17, 2013 · Class I · Z-1835-2013: CareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is operating at an incorrect voltage and it could potentially experience a loss of communication between the 
- Mar 6, 2013 · Class II · Z-1112-2013: The recall was initiated because Carefusion has identified potential risk associated with bolus programming with the Alaris PC unit (model 8015) software version 9.12. Automating infusion pump paramet
- Mar 6, 2013 · Class I · Z-1098-2013: The recall was initiated because Carefusion has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module
- May 25, 2012 · Class I · Z-2076-2012: The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit power supply board that is causing an error code(120.4630) "System Error" or "Missing Battery Error" at st
- Sep 13, 2011 · Not classified · Z-0876-2012: The recall was initiated because Carefusion has identified a potential risk with a PLD component on the Alaris PC unit model 8015 power supply board. The PLD component used in production between June 
- Aug 2, 2010 · Not classified · Z-0492-2011: Than recall was initiated because CareFusion has identified identified a potential risk associated with the Alaris PC unit formerly known as Medley PC unit (PC Unit) model 8000 only when used with Ala
- Jul 13, 2010 · Not classified · Z-0006-2011: Under certain wireless network conditions a communication error can occur, which freezes the PC Unit screen, which may result in a delay of therapy. A delay of therapy may result in serious injury and
- Jun 12, 2009 · Not classified · Z-1790-2009: There is a potential risk for medication not being delivered when IV tubing sets are occluded in the Alaris Pump module. This can occur if IV sets are set up in the infusion pumps but not used for an 
- Jun 12, 2009 · Not classified · Z-1791-2009: Affected Unit: Alaris PC Unit (Models 8000 and 8015) with software a versions 8 and above when used with the Alaris PCA module (Model 8120) There is a potential risk of over infusion related to a warn
- Jun 12, 2009 · Not classified · Z-1794-2009: 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 visua
- Jun 12, 2009 · Not classified · Z-1792-2009: There is a potential in the specified ESD (electrostatic discharge) protection circuitry in the keypad of Alaris PC units manufactured or serviced between April 2008 through January 2009. In these uni

## Indications for use
The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules (aka Medley System modules) intended for use in today's growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices. The specific intended use for each Alaris System module is specified in its respective submission.

Source page: https://510kreport.com/device/K051641
Methodology: https://510kreport.com/methodology