Terumo recalls CDI OneView BPM Probes with potential temperature measurement errors that could lead to incorrect patient vital signs. Affected units have specific serial numbers and model numbers. Consumers should contact Terumo for details.
Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in patient temperature without an in vivo recalibration, affected probes may experience inaccuracy in other measured parameters, including pCO2, pO2, pH, Potassium and calculated parameters, including BE, Bicarbonate, Arterial Oxygen Saturation, Delivered Oxygen, Area Under of the Curve of Delivered Oxygen, Oxygen Consumption, and Oxygen Extraction Ratio, which utilize temperature as an input. Inaccurate data may lead to inappropriate user response.
Terumo is recalling CDI OneView BPM Probes that may show inaccurate temperature readings. This could lead to incorrect patient vital signs if not addressed. The recall affects specific model numbers and serial ranges.
The probes may have assembly errors in the thermistor, causing inaccurate temperature measurements. This inaccuracy can affect other vital signs like pCO2, pO2, pH, and potassium levels. Incorrect readings might lead to improper medical decisions.
Healthcare providers using the CDI OneView BPM Probes for patient monitoring are most at risk. Patients using these devices for critical care monitoring could be affected if the probes provide inaccurate readings.
Check for model numbers CDI753 or CDI753TK and serial numbers in the ranges B0050201-B0050240. The recall covers specific batches with UDI-DI 00886799001889.
Reach out to Terumo for specific guidance on the affected units and next steps.
CDI753 and CDI753TK model numbers are affected.
Serial numbers in the ranges B0050201-B0050240.
Check the serial number on the probe against the ranges B0050201-B0050240.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-2018-2025 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-2018-2025 from Terumo. 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.
