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Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense®
EARLYSENSE LTD · Model AME-00202 HR US · UDI-DI 07290016169232
BZQ
Prescription
1
510(k) clearances
127
Adverse events (11 deaths)
3
Recalls
110
Facilities
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 |
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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.