GE Healthcare recalls CARESCAPE Monitor B450 units with specific serial numbers due to 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 B450 units that may restart repeatedly when connected to a network experiencing prolonged overload. This could interrupt patient monitoring during critical care. The recall affects specific serial numbers listed in the notice.
When multiple CARESCAPE Monitor 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.
Healthcare facilities using the CARESCAPE Monitor B450 for patient monitoring in 510(k) countries. Patients are at risk if the monitor restarts during critical care events.
Check if your monitor has a serial number starting with SJA or SNE followed by 10 digits and ending with HA or HR (e.g., SJA15150092HA). The recall covers specific serial numbers listed in the official notice.
Verify your monitor's serial number against the list of affected units provided in the recall notice.
Reach out to your healthcare facility for guidance on network adjustments if multiple monitors are connected.
The monitors may restart repeatedly when connected to a network experiencing prolonged overload, which could interrupt patient monitoring.
No, the recall does not require immediate discontinuation. Healthcare facilities should monitor network conditions and adjust as needed.
Check the serial number against the list of affected units provided in the recall notice.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0095-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0095-2019 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
