Terumo recalls specific blood monitoring devices due to H/Sat Color Chip Test failures, which disable the H/Sat module but do not affect device accuracy.
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 certain blood monitoring devices because a specific component can fail the automated self-test, disabling the H/Sat module. This issue does not cause inaccurate readings but requires replacement of the affected component.
The H/Sat Hybrid Intensity Shift feature can cause the Color Chip Test to fail in some units, which disables the H/Sat module. This issue only affects the self-test function and does not impact the device's accuracy for other blood parameters.
Users of Terumo's CDI System 500 blood monitoring devices with the specified model numbers are affected. Patients using these devices for continuous monitoring of blood parameters may be at risk if the H/Sat module fails.
Check for model numbers H011684 through H024659 in the Terumo CDI System 500 device. The affected devices include the 500AHCT and 500AVHCT monitors with specific module configurations.
Identify your monitor's model number from the list of affected serial numbers provided in the recall notice.
Contact Terumo to replace the H/Sat module if your device is affected, as the failure disables the H/Sat feature without affecting other readings.
No, the issue only disables the H/Sat module's self-test function and does not affect the device's accuracy for other blood parameters.
Check if your monitor's model number is listed in the provided range (H011684 to H024659) for the CDI System 500 devices.
No, you can continue using the monitor normally; the issue only requires replacing the H/Sat module if the self-test fails.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-2751-2018 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-2751-2018 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.
