Infinium Medical recalls CLEO and Tranquility VS Patient Monitors sold in the US that do not include temperature monitoring as part of their intended use. Affected units have specific serial numbers listed in the recall.
The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option.
Infinium Medical is recalling certain CLEO and Tranquility VS Patient Monitors sold in the US because these devices were not designed to monitor temperature. This means the monitors may not function correctly for temperature readings as intended, potentially leading to inaccurate health assessments.
The recall states that the 510(k) indications for use in the US did not include the temperature monitor accessory option. This means the monitors were not intended to measure temperature, so they may not provide accurate temperature readings when used for that purpose. Inaccurate temperature readings could lead to improper patient care decisions.
Healthcare providers using the CLEO or Tranquility VS Patient Monitors in the US are likely affected. Patients receiving care with these monitors may be at risk if temperature monitoring is required but the device does not support it.
Check the serial number on your CLEO or Tranquility VS Patient Monitor. Affected units have specific serial numbers listed in the recall, including examples like A18094501812 and A17074501202.
Look for the serial number on your CLEO or Tranquility VS Patient Monitor to determine if it is affected.
The CLEO and Tranquility VS Patient Monitors were not designed to include temperature monitoring as part of their intended use in the US, so they may not function correctly for temperature readings.
Check the serial number on your monitor against the list of affected serial numbers provided in the recall notice.
The recall does not specify a remedy, so no action is required beyond checking if your monitor is affected.
We’ve drafted a message you can send Infinium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1926-2019 — Infinium Medical Infinium Medical Hello, I own a Infinium Medical that is covered by recall Z-1926-2019 from Infinium Medical. 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.
