Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box
All Recalls
95,050 total recalls in our database
🏥 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.
Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized.
🏥 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
Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot, resulting in an incorrect flying focal spot sequence. If the system does not receive error, it would continue to complete the scan with the incorrect flying focal spot sequence, having an effect on the reconstruction of some images, resulting in image loss.
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
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 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
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
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
🏥 Medical Devices Class I - Dangerous
Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot, resulting in an incorrect flying focal spot sequence. If the system does not receive error, it would continue to complete the scan with the incorrect flying focal spot sequence, having an effect on the reconstruction of some images, resulting in image loss.
🏥 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
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.