Alaris PC unit
Medical device recall Z-1606-2016. Published in FDA’s Enforcement Report on May 11, 2016.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on May 11, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 23,397 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
23,397 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial no. 13734283 13734308 13734309 13734310 13734312 13734313 13734337 13734339 13734345 13734351 13734352 13734353 13734354 13734355 13734361 13734364 13734365 13734366 13734367 13734368 13734370 13734374 13734376 13734377 13734379…
Every code shown here, 2,000 characters
Serial no. 13734283 13734308 13734309 13734310 13734312 13734313 13734337 13734339 13734345 13734351 13734352 13734353 13734354 13734355 13734361 13734364 13734365 13734366 13734367 13734368 13734370 13734374 13734376 13734377 13734379 13734382 13734383 13734408 13734413 13734414 13734415 13734418 13734424 13734427 13734430 13734431 13734432 13734435 13734437 13734440 13734441 13734452 13734453 13734454 13734455 13734456 13734457 13734458 13734459 13734460 13734461 13734462 13734463 13734464 13734465 13734466 13734467 13734468 13734469 13734470 13734474 13734476 13734479 13734486 13734487 13734488 13734489 13734491 13734496 13734498 13734510 13734511 13734512 13734518 13734559 13734560 13734582 13734583 13734584 13734585 13734586 13734589 13734590 13734591 13734595 13734600 13734601 13734607 13734608 13734613 13734614 13734621 13734626 13734627 13734630 13734634 13734635 13734636 13734640 13734645 13734646 13734653 13734659 13734661 13734665 13734668 13734669 13734670 13734671 13734674 13734675 13734676 13734677 13734678 13734680 13734719 13734735 13734738 13734743 13734744 13734745 13734746 13734748 13734752 13734757 13734760 13734765 13734766 13734767 13734768 13734776 13734785 13734786 13734787 13734788 13734789 13734793 13734804 13734809 13734821 13734823 13734828 13734831 13734839 13734847 13734849 13734852 13734855 13734871 13734872 13734873 13734874 13734875 13734876 13734877 13734883 13734884 13734886 13734891 13734892 13734893 13734894 13734904 13734923 13734924 13734931 13734932 13734933 13734934 13734935 13734937 13734938 13734946 13734947 13734948 13734952 13734953 13734954 13734956 13734957 13734958 13734959 13734960 13734961 13734962 13734963 13734964 13734965 13734967 13734968 13734975 13734990 13734997 13735001 13735002 13735003 13735004 13735005 13735012 13735016 13735017 13735020 13735023 13735036 13735037 13735038 13735040 13735041 13735045 13735067 13735069 13735076 13735078 13735079 13735081 13735084 13735086 13735087 13735088 13735089 13735100…
FDA’s list runs to 230,726 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution: US (nationwide) and countries of: Australia, Great Britain and Canada.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 24, 2016.
- FDA classified it on May 4, 2016.
- FDA’s Enforcement Report published it on May 11, 2016.
- FDA terminated it on Jun 29, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- CareFusion 303, Inc., of San Diego, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 230,726 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.