🏥 Medical Devices Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
All Recalls
95,050 total recalls in our database
Pin hole package failures compromising sterility of product
There is a potential the joint in the suspension of the device is insufficiently assembled.
🏥 Medical Devices Class I - Dangerous
Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting.
🏥 Medical Devices Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
🏥 Medical Devices Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
🏥 Medical Devices Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
🏥 Medical Devices Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
Dental adaptor does not conform to specifications. The dental coupling of the adapter can become deformed when being inserted into the implant may make it difficult to remove the adapter from its counterpart (e.g. the handpiece).
🏥 Medical Devices 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.
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
🏥 Medical Devices Class I - Dangerous
The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality.
🏥 Medical Devices Class I - Dangerous
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
🏥 Medical Devices 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
🏥 Medical Devices Class I - Dangerous
The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.