Atlas FDA

ALARIS SYSTEM PC UNIT, MODEL 8001

FDA 510(k) clearance K051641 · decided 2005-10-20

Clearance details

K-number
K051641
Device name
ALARIS SYSTEM PC UNIT, MODEL 8001
Applicant
Cardinal Health, Alaris Products
Decision
Substantially Equivalent
Date received
2005-06-20
Decision date
2005-10-20
Days to decision
122 days
Clearance type
Traditional
Product code
FRN
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
San Diego, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit recall (Z-1645-2026)CareFusion 303, Inc.2026-03-26
BD Alaris PCU REF 8015 recall (Z-0184-2024)CareFusion 303, Inc.2023-11-07
BD Alaris Syringe Module, REF 8110 recall (Z-0185-2024)CareFusion 303, Inc.2023-11-07
Alaris PCA Module 8120 recall (Z-0186-2024)CareFusion 303, Inc.2023-11-07
CareFusion Alaris Pump Module, Model 8100 recall (Z-1360-2020)CareFusion 303, Inc.2020-03-05
CareFusion Alaris Syringe Module, Model 8110 recall (Z-1361-2020)CareFusion 303, Inc.2020-03-05
CareFusion Alaris PCA Module, Model 8120 recall (Z-1362-2020)CareFusion 303, Inc.2020-03-05
Alaris PC Unit, Model 8015 recall (Z-2671-2017)CareFusion 303, Inc.2017-06-19
Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092 recall (Z-1239-2016)CareFusion 303, Inc.2016-03-24
Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris recall (Z-1811-2015)CareFusion 303, Inc.2015-06-16
Alaris PC units, Model No. 8015. Infusion pump. recall (Z-1311-2015)CareFusion 303, Inc.2015-03-23
Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode s recall (Z-0534-2014)CareFusion 303, Inc.2013-12-20
Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly recall (Z-1835-2013)CareFusion 303, Inc.2013-08-02
Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is recall (Z-1098-2013)Carefusion Corporation2013-04-15
Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is recall (Z-1112-2013)Carefusion Corporation2013-04-15
Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only. recall (Z-2076-2012)CareFusion 303, Inc.2012-07-26
Alaris PC unit model 8015. The Alaris PC unit is the central programming, monitoring and p recall (Z-0876-2012)CareFusion 303, Inc.2012-01-26
CareFusion Alaris PC Unit Model 8015 (formerly Medley PC Unit): Alaris PC Units (Model 801 recall (Z-0006-2011)CareFusion Corporation2010-10-13
The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) with software ve recall (Z-1790-2009)Cardinal Health 303 dba Cardinal Health2009-08-03
The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) software version recall (Z-1791-2009)Cardinal Health 303 dba Cardinal Health2009-08-03
The Alaris PC Unit, Model 8015 (manufactured or serviced between April 2008 and January 20 recall (Z-1792-2009)Cardinal Health 303 dba Cardinal Health2009-08-03
Alaris System Inter-Unit Interface (IUI) Connectors. The Modules include the following: Al recall (Z-1794-2009)Cardinal Health 303 dba Cardinal Health2009-08-03