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InnoSpire Elegance
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Model 00 · UDI-DI 00383730002811
BTI
Prescription
1
510(k) clearances
5,408
Adverse events (36 deaths)
5
Recalls
72
Facilities
Description
Innospire Elegance, Custom Elegance Medical Center, 6 pack.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-29 | Datex-Ohmeda, Inc. | GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstrm Carestation/ |
| 2023-12-29 | Datex-Ohmeda, Inc. | GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstrm Carestation/ |
| 2023-12-29 | Datex-Ohmeda, Inc. | GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstrm Carestation/ |
| 2013-12-05 | Maquet Cardiovascular Us Sales, Llc | Maquet Compressor Mini may deliver compressed air at a temperature higher than specified. |
| 2007-01-26 | Draeger Medical, Inc. | Compressors not providing sufficient supply pressure to connected medical ventilator |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.