The CDI System 500 monitor displays the "H/S DISCONNECT AT CUVETTE" error message when the CDI HIS Cuvette does not make a proper connection with the CDI H/S Probe. When this occurs, blood parameter values for HCT, Hgb and S02 do not display.
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Infusion Pumps
🏥 Medical Devices • 4,262 recalls
Philips Healthcare IntelliVue Info Center iX, A.0 866023
Philips Electronics North America
Class I - Dangerous
Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.
Class I - Dangerous
Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. In rare situations, echo trend graphs may mix data from multiple patients.
BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, COMPLETE), 10462449 (BCS XP ANALYZER SYSTEM), 10461894 (BCS XP), 10470625 (BCS XP REFURBISHED); IVD --- Device Listing D060801
Siemens Healthcare Diagnostics
Class I - Dangerous
False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for false low PT INR values. These false short clotting times were observed only with turbid, hemolytic and/or icteric samples from intensive care patients. The corresponding reaction curves of these samples showed a pre-peak, which can lead to falsely short clotting time. The result was not flagged by the existing check algorithms.
EndoVive 3s Low Profile Balloon Kits Part Number: M00548420 (XMD P/N 70-0050-914)
Xeridiem Mediem Medical Devices
Class I - Dangerous
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Philips IntelliVue Measurement Module X1 Model: M3001A
Philips Electronics North America
Class I - Dangerous
The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host Monitor
Philips IntelliVue Module Measurement X2 Model: M3002A
Philips Electronics North America
Class I - Dangerous
The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host Monitor
The clip in the applier may be missing a boss. A boss is the part of the clip that is used to hold the clip within the applier jaws prior to application.
Synthes Small Electric Drive (SED)
The Anspach Effort
Class I - Dangerous
May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start.
EndoVive 3s Low Profile Balloon Kits Part Number: M00548750 (XMD P/N 70-0050-A18)
Xeridiem Mediem Medical Devices
Class I - Dangerous
A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use
Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use
Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use
Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use
Potential incorrect Standardized Uptake Values (SUV) measurements in RadSuite.
Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+)
Class I - Dangerous
Moog is recalling Curlin 4000, 6000, and PainSmart Infusion Pumps manufactured or serviced by MMDG between March 18, 2015 and November 6, 2015 because the master pumps used to calibrate them were out of tolerance and may cause an over delivery of medications and solutions at a rate of 1.2 - 6.8% faster than programmed.
Class I - Dangerous
Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance.
Synthes Small Electric Drive (SED). For use in general traumatology.
The Anspach Effort
Class I - Dangerous
The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start.
Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue.