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U.S. Department of Health and Human Services

Class 2 Device Recall TERUMO CARDIOVASCULAR SYSTEMS CORPORATION

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 Class 2 Device Recall TERUMO CARDIOVASCULAR SYSTEMS CORPORATIONsee related information
Date Initiated by FirmMarch 03, 2025
Date PostedMarch 31, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1492-2025
Recall Event ID 96331
510(K)NumberK234065 
Product Classification Monitor, blood-gas, on-line, cardiopulmonary bypass - Product Code DRY
ProductTerumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Code Information UDI/DI 00886799001882, Serial Number range: H0050095-H0050110, H0050112-H0050116, H0050118-H0050124, H0050126, H0050131-H0050134, H0050136, H0050140-H0050142
FEI Number 1828100
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor MI 48103-9586
For Additional Information Contactcustomer service
800-521-2818
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionTerumo 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 Commerce37 units
DistributionUS: IL, TX, NY, MI, FL, NV, and Australia, New Zealand
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DRY
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