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COSMED

C O S M E D SRL · Model Quark CPET · UDI-DI 18052400180188

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510(k) clearances

136

Adverse events

Recalls

Facilities

Description

The COSMED Quark Series system Is a modular system with multiple configurations, allowing the following measurements: Spirometry, Lung Function Testing, Cardiopulmonary Exercise Testing, Resting Metabolism. The system and its accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals. It is Intended to assist a clinician in the diagnosis of cardio-pulmonary disease conditions.

Recalls

Date	Firm	Reason
2017-08-15	NDDd Medical Technologies, Inc.	The CO/CO2 sensor cable harness may have lower electromagnetic shielding, which might have resulted in a non-compliance with the IEC 60601-1-2 standard. As a consequence of a lowe
2017-08-15	NDDd Medical Technologies, Inc.	The CO/CO2 sensor cable harness may have lower electromagnetic shielding, which might have resulted in a non-compliance with the IEC 60601-1-2 standard. As a consequence of a lowe
2014-12-23	Shape Medical Systems, Inc	This recall has been initiated because use of the impacted DPIs could result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment. The ma
2014-05-28	Shape Medical Systems, Inc	Shape Medical has initiated a correction due to a mandatory software upgrade for the Shape HF Cardiopulmonary Testing System prior to use of the impacted DPI lot numbers. Use of t

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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.