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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Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
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
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
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
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
Due to product label/labeling being altered from it's approved state.
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.
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
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.
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Hisun 250cc Utility Vehicles
Unknown Manufacturer
Grass can accumulate on the under-side of the utility vehicle near the exhaust pipe, posing a fire hazard.