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SpiroSphere
eResearchTechnology GmbH · Model SpiroSphere Sensor · UDI-DI 04057155000375
BTY
Prescription
1
510(k) clearances
136
Adverse events
4
Recalls
18
Facilities
Description
Spirometer sensor unit to measure inspiratory and expiratory pulmonary function
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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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.