Radiometer recalls TCM4 Base units with specific serial numbers due to display flickering and monitor unresponsiveness, which could delay patient monitoring and compromise product performance.
Reports have been received about the transcutaneous monitoring system display flickering or monitor becoming non responsive and beeping. This may result in delayed patient monitoring as well as potentially compromise the product performance.
Radiometer is recalling specific TCM4 Base units that may flicker or become unresponsive, potentially delaying patient monitoring and causing unsafe monitoring conditions. This affects medical devices used for pediatric and adult patient monitoring.
The display flickering or monitor becoming unresponsive and beeping may cause delays in detecting critical patient conditions. This could lead to compromised patient monitoring if the device fails to provide timely alerts during medical emergencies.
Healthcare providers using the TCM4 Base unit with specific serial numbers for pediatric or adult patient monitoring are most at risk. Patients relying on this device for continuous monitoring could experience delayed responses to medical issues.
Check if your TCM4 Base unit has the serial numbers listed in the recall notice (e.g., 391-880R0471N017). The device is used with specific monitor modules including TCM4, TCM40, TCM400, TOSCA, and CombiM models.
Identify your TCM4 Base unit's serial number to see if it matches the affected list provided in the recall notice.
Reach out to Radiometer Medical ApS directly for further instructions on whether your device needs repair or replacement.
The recalled device is the TCM4 Base unit with serial numbers listed in the recall notice, used with specific monitor modules including TCM4, TCM40, TCM400, TOSCA, and CombiM.
Check if your TCM4 Base unit has a serial number from the list provided in the recall notice (e.g., 391-880R0471N017).
Contact Radiometer Medical ApS directly for guidance on whether your device needs repair or replacement.
We’ve drafted a message you can send Radiometer to request your refund or repair — edit it as you like.
Subject: Recall Z-1755-2020 — Radiometer Radiometer Hello, I own a Radiometer that is covered by recall Z-1755-2020 from Radiometer. 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.
