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Urgent Field Safety Notice for MetaVision Suite, Clinical Information System& EHR by iMDsoft Ltd. PDF, 601KB, File does not meet accessibility standards Date: 11. July 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) - others
Reference 18439/23

Urgent Field Safety Notice for SINGLE USE TROCAR SETS 10/12MM by Aesculap AG PDF, 3MB, File does not meet accessibility standards Date: 11. July 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - visceral surgery
Reference 20199/23

Urgent Field Safety Notice for IntelliVue MX400-550 by Philips Medizin Systeme Böblingen GmbH PDF, 2MB, File does not meet accessibility standards Date: 11. July 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 18280/23

Urgent Field Safety Notice for Microtrays Cyt 60 by NORDIC BIOLABS AB PDF, 1MB, File does not meet accessibility standards Date: 11. July 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 18598/23

Urgent Field Safety Notice for INTESTINAL VIDEOSCOPE PSF-1 by Olympus Medical Systems Corp. PDF, 198KB, File does not meet accessibility standards Date: 11. July 2023 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 19611/23

Urgent Field Safety Notice for Diabecare DANA-i insulin pump by SOOIL Development Co. Ltd. PDF, 422KB, File does not meet accessibility standards Date: 10. July 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 19101/23

Urgent Field Safety Notice for DynaMesh-IPST-R visible by FEG Textiltechnik Forschung- und Entwicklungsgesellschaft mbH PDF, 1,016KB, File does not meet accessibility standards Date: 10. July 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 20020/23

Urgent Field Safety Notice for Medex extension s.t. by Smiths Medical ASD, lnc. PDF, 354KB, File does not meet accessibility standards Date: 07. July 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 19826/23

Urgent Field Safety Notice for Fistura catheter by F Care Systems NV PDF, 208KB, File does not meet accessibility standards Date: 06. July 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 13919/23

Urgent Field Safety Notice for CADD 50 mL and 100 mL Medication Cassette Reservoirs with Flow Stop when used with CADD-Legacy infusion pumps by Smiths Medical ASD, lnc. PDF, 956KB, File does not meet accessibility standards Date: 05. July 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 31521/22

Urgent Field Safety Notice for MP Monoblock Hip System, Trial Stem by Waldemar Link GmbH & Co. KG PDF, 1MB, File does not meet accessibility standards Date: 04. July 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 19442/23

Urgent Field Safety Notice for TruSignal SPO2 sensors by GE Healthcare Finland Oy PDF, 949KB, File does not meet accessibility standards Date: 04. July 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 19327/23

Urgent Field Safety Notice for FIVE S. sterile, for single use by Karl Storz S. & Co KG PDF, 378KB, File does not meet accessibility standards Date: 04. July 2023 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes)
Reference 19149/23

Urgent Field Safety Notice for Flow Re-Direction Endoluminal Device (FRED) by MicroVention,INC. PDF, 329KB, File does not meet accessibility standards Date: 04. July 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 18770/23

Urgent Field Safety Notice for LifePort Kidney Transporter V1.1 by Organ Recovery Systems, Inc PDF, 245KB, File does not meet accessibility standards Date: 04. July 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 18576/23

Urgent Field Safety Notice for MAHURKAR Triple Lumen Catheter and MAHURKAR High Pressure Triple Lumen Catheter by Covidien llc PDF, 1MB, File does not meet accessibility standards Date: 03. July 2023 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 18942/23

Urgent Field Safety Notice for Scewo Bro V1 by Scewo AG PDF, 135KB, File does not meet accessibility standards Date: 30. June 2023 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - mobility aids
Reference 17350/23

Urgent Field Safety Notice for RADspeed Series (Pro/Safire/CH-200/CH-200M) by Shimadzu Corporation PDF, 133KB, File does not meet accessibility standards Date: 30. June 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 17374/23

Urgent Field Safety Notice for ALIGNMENT FRAME DIST SUB ASSEM INFINITY TOTAL ANKLE SYSTEM by Wright Medical Technology PDF, 231KB, File does not meet accessibility standards Date: 30. June 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 17516/23

Urgent Field Safety Notice for Artis icono and Artis pheno by Siemens Healthcare GmbH Advanced Therapies PDF, 951KB, File does not meet accessibility standards Date: 30. June 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 17666/23

Urgent Field Safety Notice for Lojer Optima bed's accessory: Squatting bar long by Lojer OY PDF, 385KB, File does not meet accessibility standards Date: 30. June 2023 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - furnishings
Reference 18937/23

Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH PDF, 368KB, File does not meet accessibility standards Date: 30. June 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) - others
Reference 18456/23

Urgent Field Safety Notice for FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M by MicroPort Orthopedics Inc. PDF, 263KB, File does not meet accessibility standards Date: 30. June 2023 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 18442/23

Urgent Field Safety Notice for ORBIS ICU-Manager by DH Healthcare GmbH PDF, 816KB, File does not meet accessibility standards Date: 30. June 2023 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) - others
Reference 13756/23

Urgent Field Safety Notice for Hugo-System für roboterassistierte Chirurgie(RAS)-Handgelenkinstrumente, steriles Schnittstellenmodul (SIM), Endoskopadapter (EA) by Covidien llc PDF, 330KB, File does not meet accessibility standards Date: 30. June 2023 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 13394/23

Urgent Field Safety Notice for Buffer solution for automated systems by RAL DIAGNOSTICS PDF, 2MB, File does not meet accessibility standards Date: 30. June 2023 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 11252/23

Urgent Field Safety Notice for Giraffe Omnibed and Giraffe Incubator; Giraffe Warmer, Panda i.e. Warmer by Datex-Ohmeda, Inc PDF, 692KB, File does not meet accessibility standards Date: 29. June 2023 Topics: Medical devices Type: Customer information

Product group Physical therapy - climatotherapy
Reference 18614/23

Urgent Field Safety Notice for MX40 Intellivue by Philips Medical Systems PDF, 2MB, File does not meet accessibility standards Date: 29. June 2023 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 16954/23

Urgent Field Safety Notice for ProxiDiagnost N90 by Philips Medical Systems DMC GmbH PDF, 1MB, File does not meet accessibility standards Date: 29. June 2023 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 10144/23

Urgent Field Safety Notice for MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM by Aesculap AG PDF, 3MB, File does not meet accessibility standards Date: 29. June 2023 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - visceral surgery
Reference 18972/23