Hemosphere System with the following three components: HEM1 Advanced… — Class II medical device recall Z-0496-2018
Terminated recall by Edwards Lifesciences, LLC, reported 2018-02-07, distributed nationwide. Pre-procedural issues related to software defects
| Recall number | Z-0496-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Irvine, CA, United States |
| Recall initiated | 2017-10-02 |
| Classified | 2018-02-01 |
| Reported by FDA | 2018-02-07 |
| Terminated | 2020-12-14 |
| Distributed | Nationwide (US) |
| Quantity | 198 devices |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00690103196986, 00690103196993, 00690103197006 |
| Serial numbers | 13600145, 13600146, 13600147, 13600148, 13600149, 13600150, 13600151, 13600152, 13600153, 13600154, 13600155, 13600156, 13600157, 13600158, 13600159, 13600160, 13600161, 13600162, 13600163, 13600164, 13600165, 13600166, 13600167, 13600168, 13600169 and 173 more |
Product
Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic monitoring technology module and/or cable and accompanying Edwards accessories and/or disposables. It provides Edwards hemodynamic monitoring technologies through modular connections. The HemoSphere Swan-Ganz Module (HEMSGM10) is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is a multi-use device that works in conjunction with the HemoSphere Advanced Monitor, patient CCO cable and compatible Swan-Ganz catheter to acquire and process temperature data supporting intermittent cardiac output (iCO), continuous cardiac output (CCO) and right ventricular end diastolic volume (EDV) monitoring. The HemoSphere Oximetry Smart Cable (HEMOXSC100) is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation by reflectance spectrophotometry. LEDs within the oximetry cable transmit light fiber optically to the distal end of the catheter. The amount of light absorbed, refracted, and reflected depends on the relative amounts of oxygenated and deoxygenated hemoglobin in the blood. This optical intensity data is gathered by the oximetry catheter, processed by the HemoSphere Oximetry Cable, and displayed on a compatible monitoring platform. Parameter output is mixed venous oxygen saturation (SvO2) or central venous oxygen saturation (ScvO2).
Reason for recall
Pre-procedural issues related to software defects
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.