Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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Other Medical Devices
🏥 Medical Devices • 15,809 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.
Pin hole package failures compromising sterility of product
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
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
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.
Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
Elekta Instrument AB
Class I - Dangerous
The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.
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.
Drill, 2.5x135mm, AO, Item Number 502015142
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.