Food, drugs, devices › Respironics California Inc
Device recall: Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628
Respironics California Inc (Carlsbad, CA) initiated this device recall on 4 Jun 2013; FDA lists 1 product record under event 65376, classified Class I.
FDA defines Class I as 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. 6% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 24 Apr 2014. Initiation: voluntary: firm initiated. Respironics California Inc has 7 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Respironics California Inc, Carlsbad, CA.
Reason for recall
"Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue with the software on the V60 Power Management Board Assembly. If a component fails on the Power Management Board Assembly, it may cause ventilator support to be lost with potentially no audible alarm from the ventilator."
Distribution
"Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Dominican Rep.,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1537-2013 | Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 1053614 (989805612101) 1053615 (989805613391) 1053616 (989805613661) 1053617 (989805611761) 1053618 (n/a) R1053618 (n/a) 1076709 (n/a) 1076715 (989805627411) 1076716 (989805627431) 1076717… | 19,200 units total (12,060 units in US) | Class I | Terminated | 26 Jun 2013 |
Context
Other enforcement events for Respironics California Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 24 Apr 2017 | Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716, 1076717, DU | Device | Class I | 1 |
| 1 Feb 2017 | Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60 Ventilator | Device | Class II | 1 |
| 29 Oct 2014 | Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators ar | Device | Class II | 1 |
| 17 Sep 2014 | Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Mi | Device | Class I | 1 |
| 31 Jul 2012 | V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Ventilator is an assist Ventilator | Device | Class I | 1 |
| 29 Oct 2007 | Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000 | Device | Class II | 1 |
All 7 events for Respironics California Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue with the software on the V60 Power Management Board Assembly. If a component fails on the Power Management Board Assembly, it may cause ventilator support to be lost with potentially no audible alarm from the ventilator."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Dominican Rep.,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 24 Apr 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.