Class I - Dangerous
Adhesive border was not sticky enough.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Monoject Blunt Cannula, 15 G x 1-1/2" (1.829 mm x 3.8 cm) Item code: 8881202314
Cardinal Health 200
Class I - Dangerous
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
BrightView X , Model Number 882478
Philips Medical Systems (Cleveland)
Class I - Dangerous
An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
AXIOM Artis BA, Model Number 5904656
Siemens Medical Solutions USA
Class I - Dangerous
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
Monoject Blunt Cannula, 20 G x 1-1/2" (0.902 mm x 3.8 cm) Item code: 8881202363
Cardinal Health 200
Class I - Dangerous
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
RX Daytona, Model Nos. RX4040 and RX4041
Randox Laboratories, Limited
Class I - Dangerous
There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to melting of internal wires and scorch damage to the internal structure of the instrument.
U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions
LABORIE MEDICAL TECHNOLOGIES
Class I - Dangerous
Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage DC end does not meet all applicable flammability rating requirements. may lead to a potential fire hazard
AXIOM Artis BC, Model Number 5904649
Siemens Medical Solutions USA
Class I - Dangerous
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
RX Imola, Model Nos. RX4900
Randox Laboratories, Limited
Class I - Dangerous
There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to melting of internal wires and scorch damage to the internal structure of the instrument.
AXIOM Artis FC, Model Number 5904433
Siemens Medical Solutions USA
Class I - Dangerous
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
AXIOM Artis dBC, Model Number 5917054
Siemens Medical Solutions USA
Class I - Dangerous
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
AXIOM Artis MP, Model Number 5904466
Siemens Medical Solutions USA
Class I - Dangerous
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
AXIOM Artis TC, Model Number 7728350
Siemens Medical Solutions USA
Class I - Dangerous
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
Medical Intelligence Medizintechnik Gmbh
Class I - Dangerous
Sometimes, although the HexaPOD has reached the target position, the Constant Correlation Check (CCC) can be too sensitive and iGUIDE may incorrectly demand a verification scan.
AXIOM Artis dFC, Model Number 7412807
Siemens Medical Solutions USA
Class I - Dangerous
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
Artis zee biplane MN, Model Number 10094143
Siemens Medical Solutions USA
Class I - Dangerous
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
Monoject Blunt Cannula, 19 G x 1-1/2" (1.067 mm x 3.8 cm) Item code: 8881202355
Cardinal Health 200
Class I - Dangerous
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. The compatibility issue causes the software to be unusable which could result in a delay of reporting results.
Class I - Dangerous
Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and quality control failures have occurred due to contamination of R1 reagent with R3 reagent.
Class I - Dangerous
The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.