Food, drugs, devices › Respironics California Inc
Device recall: V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Ventilator is an assist Ventilator
FDA enforcement event 62848 is a device recall by Respironics California Inc of Carlsbad, CA, initiated 31 Jul 2012 and classified Class I, with 1 product record.
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. 5% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 22 Mar 2013. 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 is recalling the V60 ventilator because certain blower motor assemblies in the V60 ventilators may not meet specifications. Specifically, the impeller may not be properly seated on the blower motor shaft. This could subsequently cause the blower to cease functioning which would result in the failure of the V60 ventilator to deliver therapy to the patient due to the loss of ventilatio"
Distribution
"Worldwide Distribution - US (Nationwide) and the countries of: Australia, Belgium, Canada, China, Germany, Italy, Japan, Kuwait, Netherlands, Norway. Qatar, Saudi Arabia, Turkey, and United Kingdom."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2260-2012 | V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency,… | 197 units total (116 in the US) | Class I | Terminated | 12 Sep 2012 |
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 |
| 4 Jun 2013 | Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628 | 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 is recalling the V60 ventilator because certain blower motor assemblies in the V60 ventilators may not meet specifications. Specifically, the impeller may not be properly seated on the blower motor shaft. This could subsequently cause the blower to cease functioning which would result in the failure of the V60 ventilator to deliver therapy to the patient due to the loss of ventilatio"
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 the countries of: Australia, Belgium, Canada, China, Germany, Italy, Japan, Kuwait, Netherlands, Norway. Qatar, Saudi Arabia, Turkey, and United Kingdom."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 22 Mar 2013. "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.