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Urgent Field Safety Notice for Allura Xper and Azurion systems by Philips Medical Systems Nederland B.V. PDF, 4MB, File does not meet accessibility standards Date: 29. June 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 18794/23

Urgent Field Safety Notice for CRP FS by DiaSys Diagnostic Systems GmbH PDF, 635KB, File does not meet accessibility standards Date: 29. June 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 18791/23

Biointegral Surgical Inc. - all products Date: 28. June 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants - cardiac surgery
Reference 09058/22

Urgent Field Safety Notice for Lubinus Acetabular Cup - UHMWPE by Waldemar Link GmbH & Co. KG PDF, 2MB, File does not meet accessibility standards Date: 28. June 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 18413/23

Urgent Field Safety Notice for Carina by Drägerwerk AG & Co. KGaA PDF, 213KB, File does not meet accessibility standards Date: 28. June 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 18333/23

Urgent Field Safety Notice for Reusable intruments by EVOLUTIS SAS PDF, 338KB, File does not meet accessibility standards Date: 28. June 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 17665/23

Urgent Field Safety Notice for DxI 9000 Access Immunoassay Analyzer by Beckman Coulter Inc. PDF, 1MB, File does not meet accessibility standards Date: 28. June 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 17214/23

Urgent Field Safety Notice for CO-RE Tips; CO-RE II Tips by Hamilton Bonaduz AG PDF, 383KB, File does not meet accessibility standards Date: 28. June 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 17389/23

Urgent Field Safety Notice for Cios Select by Siemens Shanghai Medical Equipment Ltd. (SSME) PDF, 1MB, File does not meet accessibility standards Date: 28. June 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology - mobile radiological diagnostic facilities
Reference 17207/23

Urgent Field Safety Notice for Omixon HLA Twin CE by Omixon Biocomputing Ltd. PDF, 220KB, File does not meet accessibility standards Date: 28. June 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 14734/23

Urgent Field Safety Notice for Codman Cranial Access Kit without drugs by Integra LifeSciences Mansfield PDF, 434KB, File does not meet accessibility standards Date: 28. June 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - neurosurgery
Reference 18573/23

Urgent Field Safety Notice for Bilirubin Total (DCA) by Thermo Fisher Scientific Oy PDF, 2MB, File does not meet accessibility standards Date: 27. June 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 16230/23

Urgent Field Safety Notice for MEGADYNE Suction Coagulators by Megadyne Medical Products Inc. PDF, 304KB, File does not meet accessibility standards Date: 27. June 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 15910/23

Urgent Field Safety Notice for APTIO Automation by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 839KB, File does not meet accessibility standards Date: 27. June 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 14934/23

Urgent Field Safety Notice for Flexiview 8800, OEC 9800, OEC 9900 and OEC Elite by GE OEC Medical Systems, Inc. PDF, 331KB, File does not meet accessibility standards Date: 27. June 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology - X-ray image intensifiers (components of XN-01 or XN-02)
Reference 17563/23

Urgent Field Safety Notice for ZNN BACTIGUARD Bactiguard Implants by Bactiguard (South East Asia) Sdn. Bhd. PDF, 346KB, File does not meet accessibility standards Date: 24. June 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 17169/23

Urgent Field Safety Notice for Plum 360, Plum A+ & Plum A+3 infusion systems by ICU Medical, Inc., TR PDF, 383KB, File does not meet accessibility standards Date: 23. June 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 15802/23

Urgent Field Safety Notice for RevoLock Align Kits and RevoLock 4-Hole Kits by Click Medical, LLC PDF, 764KB, File does not meet accessibility standards Date: 23. June 2023 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - prostheses (exoprostheses)
Reference 15944/23

Urgent Field Safety Notice for Durepair Dura Regeneration Matrix by Medtronic Inc PDF, 775KB, File does not meet accessibility standards Date: 21. June 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants - cardiac surgery
Reference 17204/23

Urgent Field Safety Notice for Accu-Chek Solo Diabetes Manager by Roche Diabetes Care GmbH PDF, 89KB, File does not meet accessibility standards Date: 21. June 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 15790/23

Urgent Field Safety Notice for NebSmart by Aerosonn Medical Co., Ltd. PDF, 147KB, File does not meet accessibility standards Date: 21. June 2023 Topics: Medical devices Type: Customer information

Product group Physical therapy - inhalation therapy
Reference 17195/23

Urgent Field Safety Notice for Always-On Tip Tracked Instrument by Veran Medical Technologies, Inc. PDF, 125KB, File does not meet accessibility standards Date: 20. June 2023 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 17556/23

Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH PDF, 659KB, File does not meet accessibility standards Date: 20. June 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) - others
Reference 15494/23

Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH PDF, 732KB, File does not meet accessibility standards Date: 20. June 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) - others
Reference 16956/23

Urgent Field Safety Notice for Ultrasonic Soft Tissue Cutting and Sealing System by Suzhou Frankenman Medical Equipment Co., Ltd. PDF, 727KB, File does not meet accessibility standards Date: 16. June 2023 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic therapeutic equipment
Reference 16296/23

Urgent Field Safety Notice for domiflex, combiflex by Hermann Bock GmbH PDF, 735KB, File does not meet accessibility standards Date: 15. June 2023 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - furnishings
Reference 15899/23

Urgent Field Safety Notice for Elekta Unity by Elekta Ltd PDF, 315KB, File does not meet accessibility standards Date: 15. June 2023 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy
Reference 09895/23

Urgent Field Safety Notice for EndoWrist Tip-Up Fenestrated Grasper by Intuitive Surgical, Inc PDF, 425KB, File does not meet accessibility standards Date: 14. June 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 17172/23

Urgent Field Safety Notice for directSTIM Patient Programmer Charger by Aleva Neurotherapeutics SA PDF, 132KB, File does not meet accessibility standards Date: 14. June 2023 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - biostimulators
Reference 16565/23

Urgent Field Safety Notice for Allura Xper and Azurion systems by Philips Medical Systems Nederland B.V. PDF, 3MB, File does not meet accessibility standards Date: 14. June 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 16770/23