SUMMARY OF FIELD SAFETY NOTIFICATIONS / APRIL 2025
USER INFORMATION
Sistem de anestezie Carestation 620/650/650c și 750/750c / manufacturer Datex-Ohmeda, Inc, SUA
Ref. ANMDMR: 106/25
USER INFORMATION
Sistem RMN – Masă pacienti/ manufacturer Siemens Healthcare GmbH, Germania
Ref. ANMDMR: 124/25
PRODUCT RECALL
Implant dentar Microcone NI / manufacturer MEDENTiKA GmbH, Germania
Ref. ANMDMR: 129/25
USER INFORMATION
Cateter cu balon intraaortic: Linear, Mega, Sensation, & Sensation Plus IAB / manufacturer Datascope Corporation, SUA
Ref. ANMDMR: 132/25
USER INFORMATION
Monitor pentru semne vitale Welch Allyn Connex (CVSM), electrocardiograf CP150 și accesoriu pentru monitorul spot Connex al Panoului de energiei (APM) / manufacturer Welch Allyn, Inc., SUA
Ref. ANMDMR: 141/25
USER INFORMATION
LinkSymphoKnee / manufacturer Waldemar Link GmbH & Co.KG
Ref. ANMDMR: 142/25
PRODUCT RECALL
High Flow Double Lumen ST Catheter 13 Fr / manufacturer Joline GmbH & Co. KG, Germania
Ref. ANMDMR: 155/25
USER INFORMATION
Panou BIOFIRE® de identificare a hemoculturii 2 (BCID2) / manufacturer BioFire Diagnostics, LLC, SUA
Ref. ANMDMR: 156/25
USER INFORMATION
System 6/7/8/9 Reciprocating / Sternum Saw / manufacturer Stryker Instruments a division of Stryker Corporation, SUA
Ref. ANMDMR: 157/25
USER INFORMATION
Sistem laser Soltive / manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
Ref. ANMDMR: 158/25
PRODUCT RECALL
Rocket Thoracentesis Catheter 6FG & 8FG / manufacturer Rocket Medical PLC,
Ref. ANMDMR: 175/25
USER INFORMATION
Venue Go, Venue Fit / manufacturer GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC, SUA
Ref. ANMDMR: 176/25
PRODUCT RECALL
Ac sau set sutură – PDS II™, PDS Plus™, PROLENE™ și ETHIBOND EXCEL™/ manufacturer Ethicon, LLC, SUA
Ref. ANMDMR: 185/25
USER INFORMATION
CompoStop™ Platelet Storage Systems / manufacturer Fresenius Kabi AG, Germania
Ref. ANMDMR: 190/25
USER INFORMATION
DORO® Easy-Connect Navigation Adapter / manufacturer pro med instruments GmbH, Germania
Ref. ANMDMR: 193/25
USER INFORMATION
Hemapatch Woven / manufacturer Intervascular SAS, Franța
Ref. ANMDMR: 197/25
USER INFORMATION
Biograph mMR / manufacturer Siemens Healthcare GmbH, Germania
Ref. ANMDMR: 201/25
USER INFORMATION
AirLife™ Infant Heated Wire Circuits / manufacturer Vyaire Medical, Inc, SUA
Ref. ANMDMR: 208/25
USER INFORMATION
KliniTray / manufacturer Klinika Medical GmbH, Germania
Ref. ANMDMR: 209/25
USER INFORMATION
Bracketi ortodontici – Legend Medium Roth / manufacturer GC Orthodontics Europe GmbH, Germania
Ref. ANMDMR: 210/25
USER INFORMATION
Aparat de hemodializă – valva (V84) / manufacturer Fresenius Medical Care AG, Germania
Ref. ANMDMR: 213/25
USER INFORMATION
Plus Initial Drill / manufacturer JJGC Indústria e Comércio de Materiais Dentários S.A., Brazilia
Ref. ANMDMR: 215/25
USER INFORMATION
Microstream Advance, VitaLine, FilterLine / manufacturer Philips Medizin Systeme Böblingen GmbH, Germania
Ref. ANMDMR: 219/25
USER INFORMATION
UHI-4 High Flow Insufflation Unit / manufacturer Olympus Medical Systems Corporation, Japonia
Ref. ANMDMR: 222/25
USER INFORMATION
Tegaderm™ Film – Transparent Film Dressing / manufacturer 3M Deutschland GmbH, Germania
Ref. ANMDMR: 224/25
USER INFORMATION
Sophie 2020 / manufacturer Fritz Stephan GmbH, Germania
Ref. ANMDMR: 225/25
USER INFORMATION
REMISOL Advance / manufacturer Normand-Info SASU, Franța
Ref. ANMDMR: 226/25
USER INFORMATION
Centricity High Acuity Anesthesia / Critical Care / manufacturer GE Healthcare Finland Oy, Finlanda
Ref. ANMDMR: 227/25
USER INFORMATION
Cateter Neurovent-PTO / manufacturer RAUMEDIC AG, Germania
Ref. ANMDMR: 235/25
PRODUCT RECALL
Flexcel™ Carotid Shunt / manufacturer LeMaitre Vascular, Inc., SUA
Ref. ANMDMR: 245/25
USER INFORMATION
myQA iON / manufacturer IBA Dosimetry GmbH, Germania
Ref. ANMDMR: 253/25
PRODUCT RECALL
TufTex® Over-the-Wire Embolectomy Catheter, Pruitt® Occlusion Catheter, Pruitt® Irrigation Occlusion Catheter / manufacturer LeMaitre Vascular, Inc., SUA
Ref. ANMDMR: 261/25
PRODUCT RECALL
Toric Intraocular Lenses (repacked units) / manufacturer Carl Zeiss Meditec AG, Germania
Ref. ANMDMR: 268/25
USER INFORMATION
Creatinine / manufacturer Beckman Coulter Inc., SUA
Ref. ANMDMR: 285 /25
USER INFORMATION
Cardiosave Intra-Aortic Balloon Pumps / manufacturer Datascope Corp., SUA
Ref. ANMDMR: 296/25
USER INFORMATION
Cardiohelp System / manufacturer Maquet Cardiopulmonary GmbH, Germania
Ref. ANMDMR: 300/25
USER INFORMATION
ORTHO VISION Analyzers / manufacturer QuidelOrtho (Ortho Clinical Diagnostics Inc), SUA
Ref. ANMDMR: 303/25
USER INFORMATION
Tempus Pro / manufacturer Remote Diagnostic Technologies Ltd., Marea Britanie
Ref. ANMDMR: 307/25
USER INFORMATION
Tempus Pro / manufacturer Remote Diagnostic Technologies Ltd., Marea Britanie
Ref. ANMDMR: 308/25
PRODUCT RECALL
Lentile intraoculare: enVista Aspire™ /Toric/ Enhanced Monofocal/Monofocal Toric/ SimplifEye Preloaded Combo Kit / SimplifEye Preloaded Combo Kit Toric / manufacturer Bausch & Lomb Incorporated, SUA
Ref. ANMDMR: 326/25
USER INFORMATION
Endopath Echelon™ Vascular White Reload / manufacturer ETHICON ENDO-SURGERY, LLC, SUA
Ref. ANMDMR: 381/25
USER INFORMATION
Sistem RM cu tunel de 60 cm lățime / manufacturer Philips Medical Systems Nederland B.V., Olanda
Ref. ANMDMR: 428/25
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.