circul pro, x-large
BodiMetrics, LLC · Model O2-77-MX · UDI-DI 00850033422085
Description
The circul pro Ring is a small, wearable, non-invasive device to be worn on one finger which features an adjustable fit for comfort. It can be worn on either hand. The ring has a retractable spring design, which automatically adjusts the tightness of the ring and fixates the sensor array to the wearer’s finger. The ring has advanced photoelectric signal detection and processing methods which detect and analyze blood oxygen saturation and pulse rate. The circul™ pro Ring is a wireless, non-invasive, and stand-alone pulse oximeter intended to be used for spot-check and/or continuous data collection of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through the index finger in adult patients. It can be used in hospitals and home environments for up to twelve hours in non-motion and well perfused conditions.
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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