Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716,…
Medical device recall Z-2061-2017. Published in FDA’s Enforcement Report on May 24, 2017.
- FDA Class I
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 24, 2017. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 30,516 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 I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Over time, low-frequency vibrations can cause the pins within the female connectors on the Motor Controller to Data Acquisition Board ribbon cable to become partially displaced causing momentary high resistance that prevents or restricts data travelling through the cable during the high resistance event.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716, 1076717, DU1053617, U1053617. Old Material No. 850008, 989805628251, 989805612101, 989805613391, 989805613661, 989805611761, 989805627411, 989805627431, 989805627441, 989805616411, 989805636631.
30,516 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
As-Shipped System Serial Number 100027294 100061625 100061627 100061638 100061640 100061641 100073201 100073243 100073250 100073259 100084756 100120124 100120850 201003948 201009965 201009974 100003256 100003311 100004748 100005812…
Every code shown here, 1,992 characters
As-Shipped System Serial Number 100027294 100061625 100061627 100061638 100061640 100061641 100073201 100073243 100073250 100073259 100084756 100120124 100120850 201003948 201009965 201009974 100003256 100003311 100004748 100005812 100005814 100005902 100005983 100006103 100006113 100006172 100006173 100006174 100006176 100006185 100007117 100007119 100007191 100007197 100007209 100007334 100007341 100007414 100007418 100007422 100007536 100007539 100007543 100007768 100007769 100007770 100007771 100007776 100007780 100007781 100007782 100007786 100007879 100007882 100007888 100010702 100010703 100010707 100010708 100010709 100010710 100010712 100010720 100010851 100010853 100010902 100010904 100010905 100010911 100011043 100011045 100013961 100013965 100013970 100013971 100014010 100014469 100014483 100014489 100014516 100014770 100014772 100014773 100014775 100014776 100014778 100014822 100014823 100014824 100014825 100014826 100014827 100014828 100014830 100014896 100014897 100014899 100015329 100015330 100015331 100015332 100015334 100015337 100015382 100017355 100019389 100019394 100019397 100019398 100019722 100019828 100019832 100019835 100019974 100020049 100020056 100020058 100020062 100020064 100020114 100020125 100020169 100020172 100020173 100020651 100020653 100021172 100021402 100022243 100024705 100024710 100024712 100024878 100024879 100024880 100024883 100024885 100024888 100024889 100024894 100024896 100024897 100024900 100024901 100026665 100026666 100026673 100026674 100026680 100026684 100026758 100026759 100026763 100029455 100029461 100029470 100030106 100030107 100030108 100030109 100030110 100030111 100030112 100030113 100030114 100030115 100030116 100030117 100030118 100030120 100030121 100030123 100030125 100030128 100030129 100030130 100030132 100030135 100053050 100053788 100053793 100053794 100053795 100053796 100053797 100053855 100053856 100053859 100053860 100053865 100054152 100054153 100054154 100054156 100054157 100054158…
FDA’s list runs to 332,756 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: Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Hong Kong, Iceland, India, Indonesia, Iran (Islamic Republic Of), Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Republic Of, Kuwait, Lebanon, Libyan Arab Jamahiriya, Malaysia, Malta, Mexico, Monaco, Morocco, Namibia, Netherlands, Netherlands Antilles, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Province Of China, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Viet Nam.
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 Apr 24, 2017.
- FDA classified it on May 17, 2017.
- FDA’s Enforcement Report published it on May 24, 2017.
- FDA terminated it on Aug 13, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Respironics California Inc, of Carlsbad, 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 332,756 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.