SUMMARY OF FIELD SAFETY NOTIFICATIONS / JUNE 2024
USER INFORMATION
STANDARDTM F2400 Analyzer / manufacturer SD BIOSENSOR, Inc., Coreea
Ref. ANMDMR: 303.402/24
USER INFORMATION
All BiPAP A30, BiPAP A30 EFL, BiPAP A30 Hybrid, BiPAP A40, BiPAP A40 EFL, BiPAP A40 Pro Ventilators / manufacturer Respironics, Inc., SUA
Ref. ANMDMR: 303.403/24
USER INFORMATION
Cărucior cu înălţime reglabilă (HA) FlexTrak / manufacturer Philips Medical Systems Nederland B.V., Olanda
Ref. ANMDMR: 303.404/24
USER INFORMATION
MUTARS® RS stems and MUTARS® RS Extension pieces / manufacturer Implantcast GmbH, Germania
Ref. ANMDMR: 303.442/24
USER INFORMATION
Imunoglobulina M (IgM) / manufacturer Beckman Coulter Ireland Inc., Irlanda
Ref. ANMDMR: 303.449/24
USER INFORMATION
ORBIS Medication 3.x / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 303.492/24
PRODUCT RECALL
Aqualine family of tubing sets for Aquarius System / manufacturer Haemotronic S.p.A., Italia
Ref. ANMDMR: 303.495/24
USER INFORMATION
OmniLab Advanced + (OLA+) ventilators / manufacturer Respironics, Inc., SUA
Ref. ANMDMR: 303.515/24
USER INFORMATION
BD BBL™ Sensi-Disc™ / manufacturer Becton, Dickinson and Company, SUA
Ref. ANMDMR: 303.593/24
USER INFORMATION
SYNCHRO Guidewires / manufacturer Stryker Neurovascular, SUA
Ref. ANMDMR: 303.596/24
USER INFORMATION
RocheDiabetes® Care Platform / manufacturer Roche Diabetes Care GmbH, Germania
Ref. ANMDMR: 303.616/24
USER INFORMATION
Cholesterol / manufacturer Thermo Fisher Scientific Oy, Finlanda
Ref. ANMDMR: 303.617/24
USER INFORMATION
Defibrilator extern automat BeneHeart C / manufacturer Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Ref. ANMDMR: 303.618/24
USER INFORMATION
Hintermann Series H3 Total Ankle Replacement System / manufacturer DT MedTech, LLC, A Vilex Company, SUA
Ref. ANMDMR: 303.625/24
USER INFORMATION
QIAcube® Connect MDx instrument / manufacturer QIAGEN GmbH, Germania
Ref. ANMDMR: 303.648/24
USER INFORMATION
Real Intelligence CORI / manufacturer Blue Belt Technologies, Inc., SUA
Ref. ANMDMR: 303.650/24
USER INFORMATION
VIDAS® FPSA / manufacturer bioMérieux SA, Franta
Ref. ANMDMR: 303.687/24
USER INFORMATION
BIOFIRE® FILMARRAY® Pneumonia and Pneumonia Panel plus / manufacturer BioFire Diagnostics, LLC, SUA
Ref. ANMDMR: 303.688/24
PRODUCT RECALL
Marimer inhalații, apa de mare hipertonica 2,2% 30 x 5 mL / manufacturer Laboratoires Gilbert, Franta
Ref. ANMDMR: 303.690/24
USER INFORMATION
Opera T90-SH, Opera T90-SHX / manufacturer GMM General Medical Merate SPA, Italia
Ref. ANMDMR: 303.691/24
PRODUCT RECALL
Setpack® Sterile surgical jersey (made from cotton), Kitpacks containing the jersey component / manufacturer Lohmann & Rauscher International GmbH & Co.KG, Germania
Ref. ANMDMR: 303.692/24
USER INFORMATION
CALiaGold® pierceTube / manufacturer SENTINEL CH. S.p.A., Italia
Ref. ANMDMR: 303.710/24
USER INFORMATION
AXIOM MULTIX MT, AXIOM MULTIX MP, AXIOM Vertix MD, AXIOM Vertix Solitaire, MULTIX Swing, MULTIX TOP Systems / manufacturer Siemens Healthcare GmbH, Germania
Ref. ANMDMR: 303.756/24
USER INFORMATION
BeneHeart D1 Automated External Defibrillator / manufacturer SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD., China
Ref. ANMDMR: 303.757/24
USER INFORMATION
Horizon X-Ray Bone Densitometer (DXA) / manufacturer Hologic, Inc., SUA
Ref. ANMDMR: 303.758/24
USER INFORMATION
SIGNA™ Architect, SIGNA™ Pioneer, SIGNA™ Hero, SIGNA™ Premier, 3.0T SIGNA™ HDxt Family, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA™ PET/MR, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA™ Artist, SIGNA™ Voyager, 1.5T SIGNA™ HDxt Family, SIGNA™ Creator, SIGNA™ Explorer, SIGNA™ MR380, SIGNA™ MR355, SIGNA™ MR360, Brivo MR355, Optima MR360, SIGNA™ Prime, SIGNA™ Victor, SIGNA™ UHP, Discovery MR950, SIGNA™ 7.0T, SIGNA™ MAGNUS / manufacturer GE Medical Systems LLC, SUA
Ref. ANMDMR: 303.759/24
USER INFORMATION
Ventilator Leoni plus HFO, Leoni plus Transport / manufacturer Löwenstein Medical SE & Co. KG, Germania
Ref. ANMDMR: 303.795/24
USER INFORMATION
Sisteme RMN supraconductoare Vantage Titan MRT-1504, Vantage Titan MRT- 2004, Vantage Titan (Helios) MRT-1504, Vantage Elan MRT-2020, Vantage Orian MRT-1550, Vantage Orian Vantage Fortian MRT- 1550, Vantage Orian (XGO) MRT-1550 / manufacturer Canon Medical Systems Corporation, Japonia
Ref. ANMDMR: 303.796/24
USER INFORMATION
Alinity hq Analyzer / manufacturer Abbott Laboratories, SUA
Ref. ANMDMR: 303.863/24
USER INFORMATION
Wired Avalon Ultrasound Transducer / manufacturer Philips Medizin Systeme Böblingen GmbH, Germania
Ref. ANMDMR: 303.865/24
USER INFORMATION
LDH-P, opt. DGKC / manufacturer DIALAB – Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H., Austria
Ref. ANMDMR: 303.866/24
USER INFORMATION
Piccolo® General Chemistry 13/ manufacturer Abaxis, Inc., SUA
Ref. ANMDMR: 303.886/24
USER INFORMATION
Papaina / manufacturer DIALAB – Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H., Austria
Ref. ANMDMR: 303.905/24
USER INFORMATION
NADAL® Troponin I Test / manufacturer nal von minden GmbH, Germania
Ref. ANMDMR: 304.063/24
USER INFORMATION
Exoplan / manufacturer exocad GmbH, Germania
Ref. ANMDMR: 304.065/24
USER INFORMATION
Wireless Footswitch Model TFL-AFSWL for Soltive Models Pro TFL-SLS and Premium TFL-PLS / manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
Ref. ANMDMR: 304.067/24
USER INFORMATION
Lampi chirurgicale iLED 7 / manufacturer Baxter Medical Systems GmbH +Co. KG, Germania
Ref. ANMDMR: 304.074/24
PRODUCT RECALL
CapioTM SLIM – Dispozitiv de prindere a suturilor / manufacturer Boston Scientific Corporation, SUA
Ref. ANMDMR: 304.077/24
USER INFORMATION
Centricity High Acuity Anesthesia (CHA A) / manufacturer GE Healthcare Finland Oy, Finlanda
Ref. ANMDMR: 304.091/24
USER INFORMATION
Sistem de monitorizare a nervilor NIM Vital™ / manufacturer Medtronic Xomed, Inc., SUA
Ref. ANMDMR: 304.103/24
USER INFORMATION
Monitor defibrilator DEFIGARD Touch7 / manufacturer SCHILLER MEDICAL, Franta
Ref. ANMDMR: 304.281/24
USER INFORMATION
Ventilatoare Puritan Bennett™ seria 500 / manufacturer Covidien llc, SUA
Ref. ANMDMR: 304.282/24
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.