SUMMARY OF FIELD SAFETY NOTIFICATIONS / OCTOMBER 2024
USER INFORMATION
Reusable and Single Use Flow Sensors / manufacturer SLE Ltd, Germania
Ref. ANMDMR: 305.797c/24
USER INFORMATION
CoaguChek PT 2×24 Test / manufacturer Roche Diagnostics GmbHa, Germania
Ref. ANMDMR: 305.989/24
USER INFORMATION
Masă de operație TruSystem 7000 – Semnal de siguranță pentru evenimente termice legate de baterie / manufacturer Baxter Medical Systems GmbH + Co. KG, Germania
Ref. ANMDMR: 305.990/24
USER INFORMATION
UroPass® Ureteral Access Sheath Set / manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
Ref. ANMDMR: 305.993/24
USER INFORMATION
Sterilizable Internal Defibrillation Paddles / manufacturer Stryker Medical (Physio-Control, Inc.), SUA
Ref. ANMDMR: 306.012/24
USER INFORMATION
Trilogy Evo, Trilogy Evo O2, and Trilogy EV300 / manufacturer Philips Respironics, Inc., SUA
Ref. ANMDMR: 306.013/2024
USER INFORMATION
respons®940 systems / manufacturer DiaSys Diagnostic Systems GmbH, Germania
Ref. ANMDMR: 306.102/24
USER INFORMATION
Bronchovideoscope, EVIS EXERA III Gastrointestinal Videoscope, EVIS EXERA III Small Intestinal Videoscope, Gastrointestinal Videoscope / manufacturer Olympus Medical Systems Corporation, Japonia
Ref. ANMDMR: 306.110/24
USER INFORMATION
Ventilator ParaPAC plus™ Model 300 și Model 310/ manufacturer Smiths Medical ASD Inc. (currently “ICU Medical Inc.”), SUA
Ref. ANMDMR: 306.124/24
USER INFORMATION
Ventilator ParaPAC plus™ Model 300 și Model 310/ manufacturer Smiths Medical ASD Inc. (currently “ICU Medical Inc.”), SUA
Ref. ANMDMR: 306.125/24
USER INFORMATION
Carbon fiber side guards with untrimmed edge/ manufacturer Panthera AB, Suedia
Ref. ANMDMR: 306.126/24
USER INFORMATION
LIFE 21 apheresis unit / manufacturer Miltenyi Biotec B.V. & Co. KG, Germania
Ref. ANMDMR: 306.142/24
USER INFORMATION
UroPass® Ureteral Access Sheath Set / manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
Ref. ANMDMR: 306.153/24
USER INFORMATION
Kit de diagnosticare in vitro (IVDD) Mentype® AMLplexQS / manufacturer BIOTYPE GmbH, Germania
Ref. ANMDMR: 306.202/24
USER INFORMATION
Alegria 2 / manufacturer ORGENTEC Diagnostika GmbH, Germania
Ref. ANMDMR: 306.204/24
USER INFORMATION
POLARx™ and POLARx™ FIT Cryoablation Catheter – Instructions for Use / manufacturer Boston Scientific Corporation, SUA
Ref. ANMDMR: 306.209/24
USER INFORMATION
Ulei siliconic /manufacturer D.O.R.C. Dutch Ophthalmic Research Center (International) B.V., Olanda
Ref. ANMDMR: 306.210/24
USER INFORMATION
Lampă chirurgicală Merivaara Q-FLOW / manufacturer Merivaara Corporation, Finlanda
Ref. ANMDMR: 306.216/24
USER INFORMATION
ARCHITECT i2000SR Processing Module/ manufacturer Abbott Laboratories, SUA
Ref. ANMDMR: 306.253/24
USER INFORMATION
Jasper™ HPLC System / manufacturer AB SCIEX Pte. Ltd., Singapore
Ref. ANMDMR: 306.273/24
PRODUCT RECALL
Network-isolator Cat.6A for healthcare / manufacturer EFB Elektronik GmbH, Germania
Ref. ANMDMR: 306.278/24
PRODUCT RECALL
MAJ-1555 Single Use Biopsy Valve / manufacturer Olympus Medical Systems Corporation, Japonia
Ref. ANMDMR: 306.279/24
USER INFORMATION
respons®940 systems/ manufacturer Dh Healthcare Gmbh, Germania
Ref. ANMDMR: 306.281/24
USER INFORMATION
respons®940 systems / manufacturer DiaSys Diagnostic Systems GmbH, Germania
Ref. ANMDMR: 306.286/24
USER INFORMATION
Sisteme de pompă MiniMedTM seria 600 și seria 700 / manufacturer Medtronic Minimed, SUA
Ref. ANMDMR: 306.366/24
USER INFORMATION
CA 72-4 ELISA / manufacturer IBL International GmbH, Germania
Ref. ANMDMR: 306.371/24
USER INFORMATION
Olympus GIF-1TH190 Gastrointestinal Videoscope / manufacturer Olympus Medical Systems Corporation, Japonia
Ref. ANMDMR: 306.380/24
USER INFORMATION
SD UroColor 10/ UroColor 10, SD UroColor 11/ UroColor 11 / manufacturer Abbott Diagnostics Korea Inc. (Old name : Standard Diagnostics, Inc.), Koreea
Ref. ANMDMR: 306.383/24
USER INFORMATION
Potential Loss of Electrical Grounding – IntelliVue Patient Monitor Power Supply / manufacturer Philips Medizin Systeme Boblingen GmbH, Germania
Ref. ANMDMR: 306.389/24
USER INFORMATION
Flow Sensors Nebulized Aerosol Deposition with Trilogy Evo, Trilogy Evo O2, Trilogy EV300/ manufacturer Philips Respironics, Inc, SUA
Ref. ANMDMR: 306.391/24
USER INFORMATION
Users of mint Lesion™ versions from 3.8.6 up to and including 3.9.2 / manufacturer Mint Medical GmbH, Germania
Ref. ANMDMR: 306.392/24
PRODUCT RECALL
Navitor™ Transcatheter Aortic Heart valves / manufacturer Abbott Medical, SUA
Ref. ANMDMR: 306.393/24
USER INFORMATION
Nutrifix Bag – Infusomat Space Line ENFit / manufacturer B.Braun Melsungen AG, Germania
Ref. ANMDMR: 306.396/24
USER INFORMATION
Centricity Universal Viewer Zero Footprint Client (ZFP) / manufacturer GE Healthcare, SUA
Ref. ANMDMR: 306.425/24
USER INFORMATION
TCM5 monitor / manufacturer Radiometer Medical ApS, Danemarca
Ref. ANMDMR: 306.426/24
USER INFORMATION
Depunere de aerosoli obţinuţi prin nebulizare pe senzorii de debit Trilogy Evo, Trilogy Evo O2, Trilogy EV300 / manufacturer Philips Respironics, Inc., SUA
Ref. ANMDMR: 306.433/24
PRODUCT RECALL
Cutter agresiv, Rezector cu rază completă, Lamă răzuitor agres. Pro Line, Trepan rotund, Trepan cilindric agresiv, Trepan cilindric pentru finisare, Trepan cilindric cu semi-capac protector, Trepan cilindric agresiv/ manufacturer KARL STORZ SE & Co. KG, Germania
Ref. ANMDMR: 306.435/24
USER INFORMATION
nal von minden Drug-Screen® COC 300 Test / manufacturer nal von minden GmbH, Germania
Ref. ANMDMR: 306.449/24
USER INFORMATION
BiPAP A40 Pro, BiPAP A40 EFL and BiPAP A30 EFL Ventilators Alarm Malfunction / manufacturer Philips Respironics, Inc., SUA
Ref. ANMDMR: 306.489/24
PRODUCT RECALL
The Femoral ACL Marking Hook, AM Portal, 7 mm Offset / manufacturer Arthrex INC, SUA
Ref. ANMDMR: 306.502/24
USER INFORMATION
Software Update for Alegria 2 / manufacturer ORGENTEC Diagnostika GmbH, Germania
Ref. ANMDMR: 306.503/24
USER INFORMATION
Sistemele Zenition 50 şi Zenition 70 / manufacturer Philips Medical Systems Nederland BV, Olanda
Ref. ANMDMR: 306.505/24
PRODUCT RECALL
Opraclean Ribbon Gauze for packing with Iodoform 5m x 1 cm / manufacturer Lohmann & Rauscher International GmbH & Co. KG, Germania
Ref. ANMDMR: 306.534/24
USER INFORMATION
KayserBetten GmbH & Co. KG – KayserBett OLAF 98, KayserBett OLAF 135 / manufacturer KayserBetten GmbH & Co. KG, Germania
Ref. ANMDMR: 306.535/24
USER INFORMATION
KayserBett OLAF paediatric care bed / manufacturer ayserBetten GmbH & Co. KG, Germania
Ref. ANMDMR: 306.536/24
USER INFORMATION
Wound care dressings / manufacturer Advanced Medical Solutions, Marea Britanie
Ref. ANMDMR: 306.563/24
PRODUCT RECALL
Medizym® anti-GAD M / manufacturer Medipan GmbH, Germania
Ref. ANMDMR: 306.564/24
USER INFORMATION
Universal Remote Control / manufacturer MAQUET GmbH, Germania
Ref. ANMDMR: 306.565/24
USER INFORMATION
Incidin Oxywipe S / manufacturer Ecolab Deutschland GmbH, Germania
Ref. ANMDMR: 306.567/24
USER INFORMATION
EarlyCDT Lung Cancer Test Kit / manufacturer Freenome Ltd, Germania
Ref. ANMDMR: 306.568/24
USER INFORMATION
Replacement of Batteries for Orchestra and Pilot ranges / manufacturer Fresenius Kabi AG, Germania
Ref. ANMDMR: 306.569/24
USER INFORMATION
Catetere PowerPICCsingle lumen 4Fr / manufacturer Bard Access Systems, Inc, SUA
Ref. ANMDMR: 306.695/24
USER INFORMATION
Atlan anaesthesia workstations/ manufacturer Drägerwerk AG & Co. KGaA, Germania
Ref. ANMDMR: 306.700/24
PRODUCT RECALL
TM-CA 72-4 ELISA / manufacturer DRG Instruments GmbH, Germania
Ref. ANMDMR: 306.701/24
USER INFORMATION
GeneProof Aspergillus PCR Kit / manufacturer GeneProof a.s., Cehia
Ref. ANMDMR: 306.702/24
USER INFORMATION
Olympus Laser Cystoscope / manufacturer Olympus Winter & Ibe GmbH, Germania
Ref. ANMDMR: 306.705/24
USER INFORMATION
Paediatric care bed KayserBett EMMA, KayserBett IDA / manufacturer KayserBetten GmbH & Co. KG, Germania
Ref. ANMDMR: 306.706/24
PRODUCT RECALL
Hemospray Endoscopic Hemostat / manufacturer Cook Endoscopy/Wilson Cook Medical, Inc., SUA
Ref. ANMDMR: 306.726/24
USER INFORMATION
ETD Premium PAA, ETD Premium GA / manufacturer Miele & Cie. KG, Germania
Ref. ANMDMR: 306.728/24
USER INFORMATION
mylife App / manufacturer SINOVO health solutions GmbH, Germania
Ref. ANMDMR: 306.729/24
PRODUCT RECALL
Axillary Insertion Introducer and Introducer Kits – Risk of Infection / manufacturer Oscor Inc, SUA
Ref. ANMDMR: 306.730/24
USER INFORMATION
Introducător și ghiduri reutilizabile pentru tuburi traheale/ manufacturer ICU Medical Inc, SUA
Ref. ANMDMR: 306.731/24
USER INFORMATION
BD BACTEC™ Blood Culture System, BD Phoenix™ M50 Automated
Microbiology System, BD MAX™ System, BD COR™ System, BD EpiCenter™ Microbiology Data
Management System, BD Synapsys™ Informatics Solution / manufacturer Becton, Dickinson and Company, SUA
Ref. ANMDMR: 306.735/24
USER INFORMATION
Remote controlled radiology system: PLATINUM dRF (8L) / manufacturer APELEM, Franța
Ref. ANMDMR: 306.829/24
USER INFORMATION
Cistoscop cu laser Olympus / manufacturer Olympus Winter & Ibe GmbH, Germania
Ref. ANMDMR: 306.856/24
USER INFORMATION
Dispozitive vâscochirurgicale oftalmice (OVD)- Visthesia 1.5% /manufacturer Hyaltech Ltd, Germania
Ref. ANMDMR: 307.128/24
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.