Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message.
Drill Sys2.7, 2x103mm, AO, Item Number 502015107
Zimmer GmbH
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message.
Table assembly error with incorrect actuators for the lateral and longitudinal table movements
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.