Terumo recalls CDI Blood parameter monitoring system 500 H/SAT with Part No. 145883 due to Color Chip Test failures that disable the H/Sat module. No device inaccuracy occurs.
H/Sat Hybrid Intensity Shift has been seen in a subset of the H/Sat population, which has resulted in an increase of Hybrids failing the H/Sat Color Chip Test which is an automated self-test when the device is powered on. This will not result in device inaccuracy, only Color Chip Test Failure which disables the H/Sat module.
Terumo is recalling its CDI Blood parameter monitoring system 500 H/SAT model with Part No. 145883. This device may show Color Chip Test failures that disable the H/Sat module, but it does not affect the accuracy of blood measurements.
The H/Sat Hybrid Intensity Shift feature causes some units to fail the Color Chip Test, which disables the H/Sat module. This issue does not cause inaccurate blood measurements but prevents the device from functioning for certain tests.
Patients using the CDI Blood parameter monitoring system 500 H/SAT with Part No. 145883 for blood oxygen and other vital signs monitoring are affected. Healthcare providers using this device for critical patient monitoring are at higher risk.
Check for the CDI Blood parameter monitoring system 500 H/SAT with Part No. 145883. This model is used for continuous blood oxygen and other vital sign monitoring in medical settings.
Look for Color Chip Test failures in the device's display when powered on. This may disable the H/Sat module.
No, the device does not become inaccurate. The issue only causes the H/Sat module to disable during Color Chip Test failures.
Check for Color Chip Test failures in the device's display when powered on. If the H/Sat module disables, contact Terumo for guidance.
The recall record does not specify a fix. Users should monitor for Color Chip Test failures and contact Terumo if needed.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-2750-2018 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-2750-2018 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.
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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.
