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Respironics Domed (Gherkin)
GVS FILTER TECHNOLOGY UK LTD · Model 3400/01AIUA058/0001 · UDI-DI 15060120952537
1
510(k) clearances
19
Adverse events (1 deaths)
2
Recalls
8
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-18 | Percussionaire Corporation | Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o |
| 2005-06-08 | Medical Device Group Inc. | Device separation presenting a choking hazard. |
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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.
