The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
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Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
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.
Class I - Dangerous
The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.
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.
DLP Pressure Monitoring Extension Line Adapters 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.
Agfa Healthcare NX 3.0.8950 Imaging Processing Software
AGFA Healthcare
Class I - Dangerous
A customer reported that when using an NX workstation with software version NX 3.0.8950 software and selecting the affected patient/exam from closed exams, initially the wrong image was linked to the exam and appeared. After a short time the wrong image was replaced by the correct image, however the wrong image was used for transmitting to PACS.
Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit.
If the gantry module is replaced after original installation the configuration settings may be missing. The identified risk for this issue is electrical safety for technicians doing maintenance on the X-ray generator.
XARIO 200 TUS-X200 diagnostic ultrasound system
Toshiba American Medical Systems
Class I - Dangerous
When Continuous Trace method is used as the tracing method on Spectral Doppler in velocity trace measurement, an incorrect value may be displayed in the ultrasound systems and in the ultrasound workstations listed below.