Food, drugs, devices › Respironics California Inc
Device recall: Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators ar
FDA enforcement event 69728 is a device recall by Respironics California Inc of Carlsbad, CA, initiated 29 Oct 2014 and classified Class II, with 1 product record.
FDA defines Class II as 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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 7 Jun 2016. 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
"If the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (PCBA) and short to ground. This may prevent the ventilator to switch to battery power if AC power is disrupted."
Distribution
"Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Ecuador, Egypt, Greece, Hong Kong, India, Italy, Korea,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0485-2015 | Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Intended for use by medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and… | 3,943 units total (3,071 units in US) | Class II | Terminated | 3 Dec 2014 |
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 |
| 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 |
| 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: "If the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (PCBA) and short to ground. This may prevent the ventilator to switch to battery power if AC power is disrupted."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Ecuador, Egypt, Greece, Hong Kong, India, Italy, Korea,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 7 Jun 2016. "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.