Z-1492-2025Class II

Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754

Name: Z-1492-2025 Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Creator: Terumo Cardiovascular Systems Corporation
Published: 2025-03-03
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2025-03-03 / Open, Classified / root cause: software

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754 on 2025-03-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1492-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-03
Posted: 2025-03-31
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Product code: DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: 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
Quantity in commerce: 37 units
Distribution: US: IL, TX, NY, MI, FL, NV, and Australia, New Zealand
Product codes and lots: UDI/DI 00886799001882, Serial Number range: H0050095-H0050110, H0050112-H0050116, H0050118-H0050124, H0050126, H0050131-H0050134, H0050136, H0050140-H0050142

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1492-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1492-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-03-31

Product code DRY

K234065Class IICDI OneView Monitoring SystemTerumo Cardiovascular Systems Corporation / cleared 2024-04-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)