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SCHILLER MEDICAL · Model MAGLIFE Serenity · UDI-DI 07613365900002
MWI
Prescription
1
510(k) clearances
1,983
Adverse events (45 deaths)
81
Recalls
171
Facilities
Description
The Maglife Serenity is a multi-parameter patient monitor which is indicated for monitoring electrocardiogram (ECG), pulse oximetry (SpO2), pulse rate, partial carbon dioxide pressure at the end of expiration (EtCO2), nitrous oxide concentration (%N20), partial pressure of inspired carbon dioxide, respiratory rate (RR), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), concentration of gas inspired and expired (isoflurane, halothane, enflurane, desflurane, sevoflurane), and fraction of oxygen (FiO2) and temperature tracking.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-20 | GE Medical Systems Information Technologies Inc | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and |
| 2026-07-20 | GE Medical Systems Information Technologies Inc | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and |
| 2026-07-20 | GE Medical Systems Information Technologies Inc | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and |
| 2026-07-20 | GE Medical Systems Information Technologies Inc | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and |
| 2026-07-10 | GE Medical Systems Information Technologies Inc | Portrait Core Services Software version V1.2.0 Security Vulnerability |
| 2026-01-30 | Covidien LLC | Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring s |
| 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. |
| 2025-05-22 | CHANGE HEALTHCARE CANADA COMPANY | Due to complaints, software update may cause software to unexpectedly shutdown. |
| 2025-05-22 | CHANGE HEALTHCARE CANADA COMPANY | Due to complaints, software update may cause software to unexpectedly shutdown. |
| 2025-03-24 | Baxter Healthcare Corporation | There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batter |
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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.