Class I - Dangerous
Software defect
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Diagnostic Equipment
🏥 Medical Devices • 6,554 recalls
Rigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posirest, and were distributed as PN: 106015, 106047, 106521, 106522, 109030, and 109040 between Ocotober 2009 and July 2012 may have a height difference of approximately 17mm.
The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
Class I - Dangerous
Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the cleaning detergent solution should remain in contact with the all internal channels and external endoscope surfaces. The disinfecting solution, not the cleaning detergent, should be used for this step.
The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
Class I - Dangerous
Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the cleaning detergent solution should remain in contact with the all internal channels and external endoscope surfaces. The disinfecting solution, not the cleaning detergent, should be used for this step.
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
LeadCare II Test Kits controls out of range
There have been five reports of graft thrombosis/occlusion during global commercial use, each following treatment for BTAI. One case resulted in patient death, and three cases resulted in reintervention.
In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.
DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
Medtronic Perfusion Systems
Class I - Dangerous
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
Class I - Dangerous
The investigation demonstrated a high rate of very major errors (resistant isolates calling susceptible) with the VITEK¿ 2 AST-GN colistin (cs01n) compared to agar dilution (the reference method used for cs01n development) and compared to broth-microdilution (recommended method by EUCAST/CLSI).
Class I - Dangerous
An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651, lot 890199. While the kit performs accurately at FDP concentrations greater than 20 ¿g/ml, there is an observed reduction in sensitivity when FDP levels are less than 20 ¿g/ml. This reduction in sensitivity has been tied to FDP Latex Reagent lot 890199 and may result in false negatives.
Class I - Dangerous
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.