Home › HOSPITECH RESPIRATION LTD › AG100s control unit
AG100s control unit
HOSPITECH RESPIRATION LTD · Model AG100s control unit · UDI-DI 07290015409100
10
510(k) clearances
421
Adverse events (9 deaths)
4
Recalls
45
Facilities
Description
AnapnoGuard™ 100 system is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube’s cuff.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-22 | Hamilton Medical AG | Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by |
| 2023-08-22 | Covidien | Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external power inlet to became dislodged within the device housing after several |
| 2017-06-20 | Hamilton Medical, Inc. | Issue related to the performance of the motor in recalled product. During use, motor may cease to function. |
| 2013-08-27 | H & H Associates | Medical device tubing used for endotracheal airway application may become weakened and rendered ineffective. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.