Class I - Dangerous
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Class I - Dangerous
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Class I - Dangerous
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Class I - Dangerous
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
Philips North America
Class I - Dangerous
Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns
Class I - Dangerous
The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
Philips North America
Class I - Dangerous
Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns
O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1 for Orchestrate3d Software v.3.1 - v5.0.4
Orchestrate Orthodontic Technologies
Class I - Dangerous
Due to product label/labeling being altered from it's approved state.
Class I - Dangerous
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.
Class I - Dangerous
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Class I - Dangerous
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments.
Class I - Dangerous
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Class I - Dangerous
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545920
Boston Scientific
Class I - Dangerous
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10284473 (US) and 10488224 (OUS)
Siemens Healthcare Diagnostics
Class I - Dangerous
Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
Class I - Dangerous
Excessive ultraviolet-C radiation
INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
Wright Medical Technology
Class I - Dangerous
The package contents and package labeling do not match.
HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960
Boston Scientific
Class I - Dangerous
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure