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Respironics Domed (Gherkin)

GVS FILTER TECHNOLOGY UK LTD · Model 3400/01AIUA058/0001 · UDI-DI 15060120952537

MOD
1
510(k) clearances
19
Adverse events (1 deaths)
2
Recalls
8
Facilities

Recalls

DateFirmReason
2026-08-18Percussionaire CorporationLabeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery o
2005-06-08Medical Device Group Inc.Device separation presenting a choking hazard.

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Data 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.