October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number 40KWMOBILE3.899, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number 40KWFXPLUS-710CW, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number 40KWFXPLUS.889, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number 40KWFXPLUS.005, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number 40KWFXPLUS.004, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number 40KWFXPLUS.002, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number 40KWFXPLUS, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number 40KW-FX.899, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number 40KWFX, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Hazard: Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.
October 29, 2025Medical DevicesFDA
Becton Dickinson & Co. recalls BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro d
Hazard: Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
October 29, 2025Medical DevicesFDA
Becton Dickinson & Co. recalls BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers
Hazard: Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
October 29, 2025Medical DevicesFDA
Becton Dickinson & Co. recalls BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Cata
Hazard: Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
October 29, 2025Medical DevicesFDA
Becton Dickinson & Co. recalls BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702.
Hazard: Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
October 29, 2025Medical DevicesFDA
Becton Dickinson & Co. recalls BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number:
Hazard: Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
October 29, 2025Medical DevicesFDA
Becton Dickinson & Co. recalls BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog
Hazard: Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.