Recall Register

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Respironics California Inc

FDA recalling firm · 7 enforcement events · 7 product records · 2007–2017 · CA

Respironics California Inc has 7 FDA enforcement events on this register (7 product records) between 2007 and 2017: 7 device; the busiest year was 2014 with 2.

57% of its events are Class I; the most common class is Class I (4). 0 events are listed as ongoing; the recalling firm's address is in CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
24 Apr 2017Philips 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.DeviceClass I1Terminated
1 Feb 2017Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60 Ventilator,Intl Opt: CFLEX,AVAPS V60 Ventilator,Intl Opt: None V60 Ventilator,English Opt: None V60 Ventilator,Engl Opt: CFLEX,AVAPS V60 Us Demo Unit V60 USED ENGL OPT:CFLEX, AVAPS,PPV,AT+cl V60 VENT, JAPAN…DeviceClass II1Terminated
29 Oct 2014Esprit 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…DeviceClass II1Terminated
17 Sep 2014Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and…DeviceClass I1Terminated
4 Jun 2013Respironics 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…DeviceClass I1Terminated
31 Jul 2012V60 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,…DeviceClass I1Terminated
29 Oct 2007Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000DeviceClass II1Terminated

By type and class

Device7
Class I4
Class II3

Class I: 57% of this firm's events; 18% of all events on the register.

Events by year

07
09
11
13
15
17
19
21
23
25
Enforcement events for Respironics California Inc by year initiated.

Questions and answers

How many FDA recalls has Respironics California Inc had?

7 enforcement events (7 product records) on this register, 2007–2017: 7 device.

Are any Respironics California Inc recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Respironics California Inc recalls?

4 Class I, 3 Class II. 57% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.