Siemens Medical Solutions USA, Inc - syngo.via RT Image Suite - Class 2 Recall
syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 23, 2022 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - SOMATOM go.Up - Class 2 Recall
syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 23, 2022 Category: Medical Devices Source Type: alerts
SIGHT DIAGNOSTICS LTD - Sight OLO - Class 2 Recall
The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion. Using dedicated staining, the proposed platform provides complete blood count analysis. The Sight OLO is a compact device, designed to be automated and simple to operate, to enable rapid testing and analysis. The Sight OLO consists of a scanning and analyzing device and a CBC test kit, including disposable cartridges and sample preparation tool...
Source: Medical Device Recalls - April 22, 2022 Category: Medical Devices Source Type: alerts
SCANTILY PAD (acne treatment) liquid [Dermala Inc]
Updated Date: Thu, 17 Feb 2022 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - February 17, 2022 Category: Drugs & Pharmacology Source Type: alerts
SCANDONEST 2% L (mepivacaine hydrochloride and levonordefrin) injection, solution [Septodont, Inc.]
Updated Date: Fri, 11 Feb 2022 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - February 11, 2022 Category: Drugs & Pharmacology Source Type: alerts
SCANTILY PAD (dermala acne treatment) liquid [I Shay Cosmetics Inc]
Updated Date: Mon, 06 Dec 2021 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 6, 2021 Category: Drugs & Pharmacology Source Type: alerts
Canon Medical System, USA, INC. - Canon PETCT SCANNER, Cartesion Prime - Class 2 Recall
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 20, 2021 Category: Medical Devices Source Type: alerts
Paltop Advanced Dental Solutions Ltd - Scan Abutment WP - Class 2 Recall
Scan Abutment WP, Cat. No. 30-70106 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 5, 2021 Category: Medical Devices Source Type: alerts
Paltop Advanced Dental Solutions Ltd - Scan Abutment MU - Class 2 Recall
Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 5, 2021 Category: Medical Devices Source Type: alerts
Paltop Advanced Dental Solutions Ltd - Scan Abutment SP - Class 2 Recall
Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 5, 2021 Category: Medical Devices Source Type: alerts
Paltop Advanced Dental Solutions Ltd - Scan Abutment PCA - Class 2 Recall
Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 5, 2021 Category: Medical Devices Source Type: alerts
Paltop Advanced Dental Solutions Ltd - Scan Abutment NP - Class 2 Recall
Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 5, 2021 Category: Medical Devices Source Type: alerts
Paltop Advanced Dental Solutions Ltd - Scan Abutment SU - Class 2 Recall
Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 5, 2021 Category: Medical Devices Source Type: alerts
Simpleware Product Group, SYNOPSYS NORTHERN EUROPE - Simpleware ScanIP - Class 2 Recall
Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 13, 2021 Category: Medical Devices Source Type: alerts
Simpleware Product Group, SYNOPSYS NORTHERN EUROPE - Simpleware ScanIP Medical; Simpleware ScanIP - Class 2 Recall
Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 13, 2021 Category: Medical Devices Source Type: alerts
