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ExSpiron PadSets

Senzime AB (Publ.) · Model Adult · UDI-DI 00851540007048

BZQ BZK Prescription

510(k) clearances

127

Adverse events (11 deaths)

Recalls

111

Facilities

Description

A non-sterile, single use electrode set designed to be adhered across a patient's chest and connected to the ExSpiron Monitor for impedance pneumography. Consists of electrodes and lead wire to allow for impedance measurements across a chest cavity.

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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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.