CDI OneView Monitoring System recallZ-1492-2025 · Terumo Cardiovascular Systems Corporation · initiated Mar 3, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Terumo Cardiovascular Systems Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due to the dashed-out value.
FDA root cause category: Software design
What the company is doing
Terumo Cardiovascular issued an URGENT MEDICAL DEVICE REMOVAL notice to its consignees on 03/03/2025 via email. The notice explained the reason for the removal, potential hazard, and requested the following: 1. Review this Medical Device Correction and assure that all users have received notice of this issue. 2. Confirm receipt of this communication by completing and returning the attached Customer Response Form as indicated on the form. 3. Terumo CVS will contact users to discuss removal and correction activities. Note: Terumo CVS recommends that users continue using CDI OneView System H/S Probes while waiting for this removal
Recall details
- Recall number
- Z-1492-2025
- Status
- Open, Classified
- Initiated by the company
- Mar 3, 2025
- Posted by the FDA
- Mar 31, 2025
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 37 units
- Product code
- DRY
- FDA submissions
- K234065
- Distribution
- US: IL, TX, NY, MI, FL, NV, and Australia, New Zealand
Product description
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Code information (models, lots, serial numbers)
UDI/DI 00886799001882, Serial Number range: H0050095-H0050110, H0050112-H0050116, H0050118-H0050124, H0050126, H0050131-H0050134, H0050136, H0050140-H0050142
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CDI OneView™ Monitoring System CDI754Terumo Cardiovascular Systems Corporation · Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass1 recall1 report
Product lines
Other devices under the same FDA submission
2 devices cleared under K234065 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- CDI OneView™ Monitoring System CDI753Terumo Cardiovascular Systems Corporation · Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass4 reports
- CDI OneView™ Monitoring System CDI763Terumo Cardiovascular Systems Corporation · Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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