FDA Device Intelligence
Home › SORIN GROUP ITALIA SRL › B-CAPTA

B-CAPTA

SORIN GROUP ITALIA SRL · Model 1/2" VENOUS CUVETTE · UDI-DI 08033178113113

DRY Prescription
1
510(k) clearances
5,034
Adverse events (8 deaths)
40
Recalls
21
Facilities

Recalls

DateFirmReason
2025-05-28Terumo Cardiovascular Systems CorporationDue to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following change
2025-03-03Terumo Cardiovascular Systems CorporationDuring 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 ye
2020-09-30Maquet Cardiovascular Us Sales, LlcThe Printed Circuit Board Assembly (PCBA) are not in compliance with the IEC standard (60601 1, third edition). The BMU 40 units affected by this recall were designed with a short
2018-06-26Terumo Cardiovascular Systems CorporationH/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
2018-06-26Terumo Cardiovascular Systems CorporationH/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
2016-03-14Terumo Cardiovascular Systems CorporationSpecific CDI Blood Parameter Monitoring System 500 devices are being voluntarily recalled because the BPM Sensor Head Assemblys Thermistor, which provides the blood temperature val
2015-12-11Terumo Cardiovascular Systems CorporationTerumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying the H/S DISCONNECT AT CUVETTE error message when the CDI H/S Cuvette doe
2015-08-07Terumo Cardiovascular Systems CorporationInaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69.
2014-05-09Terumo Cardiovascular Systems CorporationThere is a potential for inaccuracies in blood gas readings/measurements. There is a potential risk of respiratory alkalosis or cerebral vasoconstriction with low paCO2. If the He
2013-02-27Terumo Cardiovascular Systems CorporationTerumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.