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ViSi
Sotera Wireless, Inc. · Model Thumb Sensor · UDI-DI 00850733007025
DQA
Prescription
1
510(k) clearances
14,142
Adverse events (362 deaths)
128
Recalls
395
Facilities
Description
The ViSi thumb sensor is an accessory intended to use together with the ViSi Mobile Monitor to measure SpQ2, pulse rate and continuous noninvasive blood pressure (cNIBP) of adult patients (18 years or older).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-24 | Edan Diagnostics | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. |
| 2025-10-24 | Edan Diagnostics | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. |
| 2025-10-24 | Edan Diagnostics | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. |
| 2025-10-24 | Edan Diagnostics | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. |
| 2025-06-23 | Covidien | Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highligh |
| 2024-09-27 | Accriva Diagnostics, Inc. | Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than |
| 2024-09-18 | Nihon Kohden America Inc | Due to oximeters not having FDA market approval or clearance to distribute in the U.S. |
| 2024-09-18 | Nihon Kohden America Inc | Due to oximeters not having FDA market approval or clearance to distribute in the U.S. |
| 2024-08-13 | Zoe Medical Incorporated | This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life. |
| 2024-08-13 | Zoe Medical Incorporated | This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life. |
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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.