GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC
Medical device recall Z-1270-2015. Published in FDA’s Enforcement Report on Mar 25, 2015.
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 Mar 25, 2015. 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
- 3,213 (437 US, 2,776 OUS) 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?
Potential failure of the caster mounting hardware, which may result in the ventilator falling/tipping (overbalancing).
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. Ventilators.
3,213 (437 US, 2,776 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg Lot or Serial # CBCP02195 CBCP02196 CBCP02201 CBCP01764 CBCP01766 CBCP02109 CBCP01273 CBCP01409 CBCP01506 CBCP01528 CBCP01533 CBCP01538 CBCP01554 CBCP01629 CBCP01630 CBCP01631 CBCP01632 CBCP01635 CBCP01636 CBCP01638 CBCP01639 CBCP01641…
Every code shown here, 2,000 characters
Mfg Lot or Serial # CBCP02195 CBCP02196 CBCP02201 CBCP01764 CBCP01766 CBCP02109 CBCP01273 CBCP01409 CBCP01506 CBCP01528 CBCP01533 CBCP01538 CBCP01554 CBCP01629 CBCP01630 CBCP01631 CBCP01632 CBCP01635 CBCP01636 CBCP01638 CBCP01639 CBCP01641 CBCP01642 CBCP01379 CBCP01380 CBCP01400 CBCP01408 CBCP01411 CBCP01417 CBCP01419 CBCP01420 CBCP01423 CBCP01425 CBCP01489 CBCP01490 CBCP01491 CBCP01494 CBCP01496 CBCP01501 CBCP01530 CBCP01540 CBCP01541 CBCP01562 CBCP01615 CBCP01619 CBCP01721 CBCP01724 CBCP01725 CBCP01726 CBCP01727 CBCP01733 CBCP01748 CBCP01116 CBCP01383 CBCP01402 CBCP01403 CBCP01429 CBCP01497 CBCP01560 CBCP01579 CBCP01580 CBCP01623 CBCP01660 CBCP01661 CBCP01704 CBCP01708 CBCP01723 CBCP01728 CBCP01730 CBCP01731 CBCP01734 CBCP01736 CBCP01737 CBCP01740 CBCP01744 CBCP01745 CBCP01746 CBCP01749 CBCP01750 CBCP01751 CBCP01755 CBCP01084 CBCP01092 CBCP01122 CBCP01248 CBCP01250 CBCP01254 CBCP01255 CBCP01258 CBCP01267 CBCP01271 CBCP01280 CBCP01236 CBCP01241 CBCP00124 CBCP00126 CBCP00130 CBCP00131 CBCP00133 CBCP00134 CBCP00139 CBCP00140 CBCP00145 CBCP00147 CBCP00148 CBCP00156 CBCP00165 CBCP00167 CBCP00170 CBCQ00598 CBCQ00643 CBCQ00650 CBCQ00662 CBCQ00666 CBCQ00667 CBCQ00668 CBCQ00690 CBCQ00998 CBCQ01003 CBCQ01008 CBCQ01009 CBCQ01010 CBCQ01011 CBCQ01013 CBCQ01014 CBCQ00941 CBCQ00942 CBCQ00946 CBCQ00957 CBCQ01018 CBCQ01023 CBCQ01029 CBCQ01038 CBCQ01041 CBCQ01045 CBCQ01048 CBCP01861 CBCP01905 CBCP01910 CBCN01376 CBCN01377 CBCN01485 CBCN01497 CBCN01504 CBCN01505 CBCN01507 CBCN01508 CBCN01509 CBCN01513 CBCN01527 CBCP00784 CBCP00795 CBCP00816 CBCP00532 CBCP00710 CBCP00747 CBCP00753 CBCP00754 CBCP01208 CBCN01858 CBCN01860 CBCN01893 CBCN01894 CBCP00831 CBCP00870 CBCP00875 CBCP00885 CBCP01627 CBCP01828 CBCP01851 CBCP01916 CBCQ00596 CBCQ00630 CBCQ00632 CBCQ00638 CBCQ00640 CBCQ00641 CBCQ00645 CBCQ00655 CBCQ00657 CBCQ00658 CBCQ00669 CBCQ00672 CBCQ00686 CBCQ00706 CBCQ00722 CBCQ00727 CBCQ00734 CBCQ00736 CBCN01901 CBCN01927 CBCN01898 CBCN01903 CBCN01907 CBCN01909 CBCP02202 CBCP02192 CBCN01445…
FDA’s list runs to 32,158 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, ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, CANADA, CAMEROON, CANDA, CHILE, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, CHANA, GREECE, GUATEMALA, HONDURAS, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LEBANON, LIBYAN ARAB JAMAHIRIYA, MACEDONIA, MALAYSIA, MALTA , MEXICO, MOROCCO, NETHERLANDS, OMAN, PANAMA, PAPUA NEW GUINEA, PERU, POLAND, PORTUGAL, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWITZERLAND, SYRIAN ARAB REPUBLIC, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM, VENEZUELA, and URUGUAY.
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 Jan 27, 2015.
- FDA classified it on Mar 13, 2015.
- FDA’s Enforcement Report published it on Mar 25, 2015.
- FDA terminated it on Feb 3, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, of Waukesha, WI.
- 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 32,158 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
-
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.