GE Healthcare recalls CARESCAPE Monitor B850 units with specific serial numbers for potential network overload causing repeated restarts. Affected units may require network adjustments to prevent interruptions in patient monitoring.
When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.
GE Healthcare is recalling certain CARESCAPE Monitor B850 units that could restart repeatedly if multiple units are connected to the same network and a network overload occurs. This might disrupt patient monitoring during critical care.
When multiple CARESCAPE Monitor B850 units are connected to the same network and a network overload happens, the monitors may restart repeatedly until the network issue is resolved. This could temporarily interrupt patient monitoring but doesn't cause injury.
Healthcare facilities using the CARESCAPE Monitor B850 for adult, pediatric, or neonatal patients. The risk is low as the issue only occurs during network overloads and doesn't cause immediate harm.
Check if your monitor has a serial number listed in the provided list of affected units (e.g., SKA14365373GA, SED11178711GA). The recall covers specific models used in 510(k) countries.
Compare your monitor's serial number with the list of affected serial numbers provided in the recall notice.
The recall is for potential network overloads that could cause repeated restarts of multiple CARESCAPE Monitor B850 units connected to the same network.
No action is needed if your monitor's serial number is not listed in the affected units.
The issue could temporarily interrupt patient monitoring during network overloads but does not cause injury or harm to patients.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0096-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0096-2019 from GE Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
