Skip to content
Get alerts
GovInfoNow
Use caution Medical device recall · FDA · Published February 4, 2020

CareFusion Alaris PC Units 8000/8015: Software Errors May Cause Therapy Interruptions

CareFusion recalls Alaris PC units 8000 (v9.5 or older) and 8015 (v12.1.0 or 9.33 or older) due to software errors that could interrupt insulin therapy. Affected users should check their device version and contact CareFusion for updates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1359-2020Medical deviceCareFusion ›
Take action

Contact the company

Recalling firmCareFusion 303, Inc.10020 Pacific Mesa Blvd · San Diego, CA 92121-4386
✎ GovInfoNow plain-language explainer

CareFusion is recalling Alaris PC units 8000 and 8015 with specific software versions because software errors might stop insulin therapy or cause incorrect medication concentrations. This could lead to serious health risks if the device fails to deliver proper treatment. Read more at govinfonow.com/recall/65885-carefusion-alaris-pc-units-8000-8015-software-errors-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/65885-carefusion-alaris-pc-units-8000-8015-software-errors-may-cause · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1359-2020

Cite this page

“CareFusion Alaris PC Units 8000/8015: Software Errors May Cause Therapy Interruptions.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65885-carefusion-alaris-pc-units-8000-8015-software-errors-may-cause. Based on FDA recall #Z-1359-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1359-2020%22&limit=1).

CareFusion 303, Inc. recalled CareFusion Alaris System PC units on Feb. 4, 2020, according to the FDA. The devices pose risks including therapy interruption and medication concentration errors due to software issues.

How to tell if you have it

  • Brand: CareFusion
  • Product: Alaris System, Alaris PC unit models 8000 and 8015
  • UDI: 10885403801518
  • Model 8000 software versions 9.5 and prior
  • Model 8015 software versions 12.1.0, and 9.33 and prior

The hazard

The recall addresses five hazards: Error 255-XX-XXX preventing settings edits; delay options programming causing no KVO rate or therapy interruption; software errors resulting in no low battery alarm or stopping infusion; medium priority alarms failing to recognize infusion completion; and custom concentration data entry errors leading to incorrect medication concentrations. The record does not report specific incidents or injuries.

Context

GovInfoNow's records show CareFusion 303, Inc. has issued 64 other recalls since June 12, 2017. Recent company actions include a Feb. 11, 2026, recall for labeling errors regarding TLS versions and a Dec. 3, 2025, software update issue for BD Pyxis ES Enterprise Server. Other recent recalls of similar products include the Medtronic MiniMed 780G insulin pump software error causing stoppage (May 27, 2026), the same model's delivery stoppage recall (Nov. 2, 2025), and the Baxter Novum IQ syringe pump infusion error recall (Aug. 11, 2026).

How to tell if you have this one

Check your Alaris PC unit model and software version. Model 8000 with software versions 9.5 or older, or Model 8015 with software versions 12.1.0 or 9.33 or older.

  • Brand
    CareFusion
  • Category
    Medical device
FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class I
  • Status
    Ongoing
  • Distribution
    Worldwide Distribution: (U.S. Nationwide) to states of: CO, SC, NY, CA, LA, TX, AK, ID, VA, DE, FL, PA, KY, KS, TN, WA, MS, IL, GA, AR, NC, NV, NE, OR, RI, WI, HI, GU, PR, MA, IA, CT, MI, AZ, ME, MT, IN, OH, WV, WY, MN, AL, NH, OK, DC, NJ, MO, SD, UT, NM, MD, VT, MP, ND, AS; and countries of: Canada, Australia, New Zealand, the Middle East, South Africa, Taiwan, Southeast Asia and the European Union.
Recall numberProduct, codes & lotsQuantity
Z-1359-2020CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518); Model 8000, software versions 9.5 and prior; Model 8015, software versions 12.1.0, and 9.33 and prior870070
Z-1360-2020CareFusion Alaris Pump Module, Model 8100; Software versions 12.1.0, and 9.33 and prior1286898
Z-1361-2020CareFusion Alaris Syringe Module, Model 8110; Software versions 12.1.0, and 9.33 and prior114835
Z-1362-2020CareFusion Alaris PCA Module, Model 8120; Software versions 12.1.0, and 9.33 and prior83015
Based on the official FDA remedy

What to do — step by step

  1. Check Device Version

    Identify your Alaris PC unit model and software version to confirm if it's affected.

  2. Contact CareFusion

    Reach out to CareFusion for guidance on updating software or other remedies.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 50 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide Distribution: (U.S. Nationwide) to states of: CO, SC, NY, CA, LA, TX, AK, ID, VA, DE, FL, PA, KY, KS, TN, WA, MS, IL, GA, AR, NC, NV, NE, OR, RI, WI, HI, GU, PR, MA, IA, CT, MI, AZ, ME, MT, IN, OH, WV, WY, MN, AL, NH, OK, DC, NJ,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 36 days after the firm started it.

1. Firm started the recall: Feb 4, 202012. FDA classified it Class I: Mar 5, 202023. Published in FDA’s Enforcement Report: Mar 11, 202032020
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

How can I update my software?

CareFusion will provide updates through their support channels; check with them directly for instructions.

Similar recalls

Medtronic MiniMed 780G Insulin Pump Recall: Software Error Causes Insulin Stoppage
MedtronicMedtronic MiniMed 780G Recall: Software Error Stops Insulin Delivery
Medtronic MiniMedSafeguard US Recalls Battle Bandages and IFAK Kits Due to Infection Risk
Safeguard US Operating LLCMiniMed Flex Insulin Pump Recall: Inaccurate Delivery Risk
Medtronic MiniMed, Inc.Medline Bariatric Rollator Recall: Detaching Wheels Risk
Medline Industries, LP

Latest medical device recalls

CooperVision, Inc. recalls Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day
CooperVision · August 12, 2026Tandem Diabetes Care, Inc. recalls Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS
Tandem Diabetes Care · July 16, 2026BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600
BMC Medical Co., Ltd. · July 15, 2026Medtronic MiniMed, Inc. recalls MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Medtr: MiniMed · July 13, 2026INTEGRATED MEDCRAFT LLC recalls Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway
Medcraft · July 7, 2026Pride Mobility Products Corp. recalls Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version:
Quantum Rehab · June 25, 2026

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1359-2020 (February 4, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1359-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.