Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Terumo Cardiovascular Systems Corporation · During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. I…
Open FDA's page for this record- Cfres ID
- 212566
- Product res number
- Z-1492-2025
- Event date initiated
- 2025-03-03
- Event date posted
- 2025-03-31
- Recall status
- Open, Classified
- Res event number
- 96331
- Product code
- DRY
- Product description
- Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
- Code info
- UDI/DI 00886799001882, Serial Number range: H0050095-H0050110, H0050112-H0050116, H0050118-H0050124, H0050126, H0050131-H0050134, H0050136, H0050140-H0050142
- Firm FEI number
- 1828100
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Address 1
- 6200 Jackson Rd
- City
- Ann Arbor
- State
- MI
- Postal code
- 48103-9586
- Additional info contact
- customer service 800-521-2818
- Root cause description
- Software design
- Product quantity
- 37 units
- Distribution pattern
- US: IL, TX, NY, MI, FL, NV, and Australia, New Zealand
- 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.
- 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
- K numbers
- K234065
- Harmonized identifiers (openFDA)
- Device name
- Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.4330
- Device class
- 2
- K number
- K852124, K874839, K881006, K133658, K915255, K871686, K900459, K202557, K972962, K862069, K903729, K234065, K931968, K955379, K900682, K854357, K012743, K862953, K062468, K071725, K110957, K123039, K202154, K973472, K843538, K133157, K091908, K103168, K941922, K861277, K173591, K955380, K980732, K181923, K072131, K871221, K915265, K910421, K831225, K821159 +7 more
- Registration number
- 1124841, 3019807891, 3000126629, 9611109, 1118880, 3002807090, 1218950, 3006073153, 1319639, 3016618143, 2184009, 3044156918, 1928237, 1828100, 2245590, 2029275, 3011560054, 3002807561, 9617601, 2011171, 9680841
- FEI number
- 3019807891, 3000204839, 3002808267, 3000126629, 1000306431, 1118880, 3005426550, 1218950, 1000116158, 3006073153, 3016618143, 3006003617, 3044156918, 1928237, 1828100, 2245590, 1000138054, 3011560054, 3002534070, 3002807561, 2011171