Baxter recalls GEM1020M-2 Flow Coupler Monitors with firmware issues causing intermittent shutdowns when WiFi is disconnected. Affected units may require firmware updates to prevent unexpected disconnections.
A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established.
Baxter is recalling GEM10:20M-2 Flow Coupler Monitors due to a firmware issue that can cause the device to shut down unexpectedly when WiFi is not connected. This could disrupt medical monitoring during procedures.
The firmware issue causes the monitor to shut down intermittently when a WiFi connection is not established. This could lead to unexpected interruptions in medical monitoring during procedures. However, the risk is not severe enough to cause serious injury in normal use.
Healthcare providers using the GEM1020M-2 Flow Coupler Monitor for medical procedures are most at risk. Patients and staff in settings where the device is used may be affected.
Check for the product code 5156-00000-011 and all serial numbers on the device. The monitor is sold as a 'Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only' product.
Verify the firmware version on the device to determine if it is affected by the recall.
The recall is for a firmware issue that may cause intermittent shutdowns when WiFi is disconnected. It does not pose a risk of serious injury in normal use.
Check for the product code 5156-00000-011 and all serial numbers on the device. The monitor is sold as a 'Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only' product.
The recall does not specify a remedy, so contact Baxter Healthcare for further instructions.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2474-2020 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-2474-2020 from Baxter 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.