There is a potential failure of the Integrated Module Housing causing the patient module parameters to drop off the monitor display or the patient module will fail to sign on when inserted into the housing.
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Diagnostic Equipment
🏥 Medical Devices • 6,554 recalls
Class I - Dangerous
SPECTROLYSE PAI-1 activity assay producing lower than expected absorbance values with "0" standard. This will reduce the slope of the standard curve requiring the user to make more frequent sample dilutions.
Class I - Dangerous
ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40
Vascular Solutions, Inc., became aware of a potential problem involving pouches missing a seal from Guardian II (Model 8210) and Guardian II NC (Model FH102) Hemostasis Valve which poses a risk of product contamination.
STERIS has learned that the Verify Bowie Dick Test Cards are not performing to product specifications. Specifically, test cards have resulted in false fail results when sterilizer performance is within acceptable ranges.
Customers may be storing objects on the base and/or around the column of the surgical table. This prohibited practice and misuse known by the customers can damage the override switch assembly located at the top of the column cover. Depending upon the nature and severity of the damage to the electronics of the table, it is possible that the table could move without prompting by an operator .
Class I - Dangerous
The impacted product was not intended for commercial distribution to end users.
Class I - Dangerous
Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
Class I - Dangerous
The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101.
Terumo Cardiovascular Systems (Terumo CVS) received complaints from our Affiliate, Terumo Dubai that the safety monitors were tripping off. Terumo CVS' investigation determined that 8 monitors were manufactured with an underrated circuit breaker due to an error where an associate pulled an underrated circuit breaker from an incorrect inventory location. Since this time, inventory locations hav
Therapy Cable Connection wear may lead to a malfunction in detection of defibrillation pads/paddles therapy Cables
Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
GE Healthcare
Class I - Dangerous
Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.
In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu
In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu
GE Healthcare has recently become aware of a potential safety issue with respect to the Innova 2121IQ & Innova 3131IQ Systems. While performing a fluoroscopic acquisition with the Innova 2121IQ or Innova 3131IQ systems, there is a potential for loss of usable imaging mode which requires the system to restart in order to recover.
Sunquest is recalling Sunquest Laboratory versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1 because when the Windows-based merge application is used and the "Event merge across patients" option is used, a receiving system (for example a HIS or CoPath system) may interpret the event merge as a full patient merge. This occurs because a trigger from the Laboratory system for the event
In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu
The display on the system has the potential to change. In house testing eventually identified the unique sequence of events that must occur in order for this issue to manifest itself.
Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
GE Healthcare
Class I - Dangerous
Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.
Leakage in Cepheid SmartCycler reaction tubes.