Home › Respiratory Motion Inc. › ExSpiron 1Xi
ExSpiron 1Xi
Respiratory Motion Inc. · Model Nurse Call Module · UDI-DI 00851540007055
10
510(k) clearances
127
Adverse events (11 deaths)
3
Recalls
112
Facilities
Description
Assembly designed to be integrated into medical facility infrastructure in order to trigger a nurse call alarm system. Designed to be used only with the ExSpiron 1Xi Monitor.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-12-21 | Salter Laboratories, Division of Regulatory Affairs | The incorrect length and connector were utilized in lot 110810 of the ThermiSense Alice 5, making the product unusable as it will not interface with the sleep labs equipment. |
| 2004-06-04 | Respironics, Inc. | Recalling firm received a product complaint from a customer that the lead wire from Model 915 battery was not connected. |
| 2004-05-24 | CAS Medical Systems, Inc. | Device may not alarm for %SpO2 value limit violations if a specific feature is enabled |
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.