SUMMARY OF FIELD SAFETY NOTIFICATIONS / MAY 2025
USER INFORMATION
Reactiv pentru creatinină / manufacturer Beckman Coulter Inc., SUA
Ref. ANMDMR: 285/25
USER INFORMATION
Olympic Brainz Monitor (DAB)/ manufacturer Natus Medical Incorporated DBA Excel -Tech Ltd. (XLTEK), Canada
Ref. ANMDMR: 341/25
USER INFORMATION
Centricity High Acuity Critical Care și Centricity High Acuity Anesthesia / manufacturer GE Healthcare Finland Oy, Finlanda
Ref. ANMDMR: 345/25
USER INFORMATION
Soltive™ SuperPulsed Laser System / manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
Ref. ANMDMR: 346/25
PRODUCT RECALL
B. subtilis inhibitor plate MiQ / manufacturer Axon Biotech GmbH, Germania
Ref. ANMDMR: 350/25
USER INFORMATION
Instinct Plus Endoscopic Clipping Device / manufacturer Cook Endoscopy/Wilson Cook Medical, Inc., SUA
Ref. ANMDMR: 359/25
USER INFORMATION
3M™ Ranger™ Blood/Fluid Warming High Flow Sets / manufacturer 3M Company, SUA
Ref. ANMDMR: 363/25
PRODUCT RECALL
Ventilatoare Leoni plus Transport / manufacturer Löwenstein Medical SE & Co. KG, Germania
Ref. ANMDMR: 364/25
PRODUCT RECALL
Ringer B. Braun / manufacturer B.Braun Melsungen AG, Germania
Ref. ANMDMR: 365/25
USER INFORMATION
Duodenoscop / manufacturer Olympus Medical Systems Corporation, Japonia
Ref. ANMDMR: 369/25
USER INFORMATION
SilverlineR ventricle probe with Cranial Bolt / manufacturer Spiegelberg GmbH & Co.KG, Germania
Ref. ANMDMR: 371/25
USER INFORMATION
ENDOPATH ECHELON™ Vascular White Reload / manufacturer Ethicon Endo-Surgery LLC, SUA
Ref. ANMDMR: 381/25
PRODUCT RECALL
Optima Coil System / manufacturer Balt USA LLC, SUA
Ref. ANMDMR: 382/25
USER INFORMATION
BX2 Needle Guide / manufacturer CIVCO Medical Instruments Co., Inc. d/b/a CIVCO Medical Solutions, SUA
Ref. ANMDMR: 386/25
PRODUCT RECALL
U-Pette®, C-Pette®, H-Pette® / manufacturer Labcon, SUA
Ref. ANMDMR: 388/25
PRODUCT RECALL
TufTex® Over-the-Wire Embolectomy Catheter, Pruitt® Occlusion Catheter, Pruitt® Irrigation Occlusion Catheter / manufacturer LeMaitre Vascular, Inc., SUA
Ref. ANMDMR: 391/25
USER INFORMATION
Aniosyme Prime, Aniosyme Synergy 5, Aniospray Quick, Anios Quick Wipes / manufacturer Laboratoires Anios, Franta
Ref. ANMDMR: 392/25
USER INFORMATION
Sisteme tratare apă: RO Medical și RO Medical Basic/ manufacturer Nipro Pure Water GmbH, Germania
Ref. ANMDMR: 393/25
USER INFORMATION
Analizoare de biochimie clinică AU480 și AU680 / manufacturer Beckman Coulter, Inc.
Ref. ANMDMR: 396/25
USER INFORMATION
Soltive Laser System / manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
Ref. ANMDMR: 397/25
USER INFORMATION
Ventilator WEINMANN MEDUMAT Standard² / manufacturer WEINMANN Emergency Medical Technology GmbH + Co. KG, Germania
Ref. ANMDMR: 403/25
PRODUCT RECALL
CarpoFit® monoblock broach / manufacturer implantcast GmbH, Germania
Ref. ANMDMR: 405/25
PRODUCT RECALL
Epicutaneo cava / manufacturer VYGON Germany GmbH, Germania
Ref. ANMDMR: 406/25
USER INFORMATION
Dexcom Non-Touchscreen Receiver / manufacturer Dexcom, Inc. SUA
Ref. ANMDMR: 411/25
PRODUCT RECALL
Impactor, iliac peg – MRS-TITAN Maximum / manufacturer Peter Brehm GmbH, Germania
Ref. ANMDMR: 412/25
PRODUCT RECALL
Set stent ureteral moale/ferm Universa® / manufacturer Cook Ireland Ltd, Irlanda
Ref. ANMDMR: 413/25
USER INFORMATION
Sisteme Centricity High Acuity Critical Care și Centricity High Acuity Anesthesia / manufacturer GE Healthcare Finland Oy, Finlanda
Ref. ANMDMR: 417/25
USER INFORMATION
Sisteme Centricity High Acuity Critical Care și Centricity High Acuity Anesthesia / manufacturer GE Healthcare Finland Oy
Ref. ANMDMR: 418/25
USER INFORMATION
Sisteme RM cu versiunile SW R11.1 și R12.1 / manufacturer Philips Medical Systems Nederland B.V., Olanda
Ref. ANMDMR: 419/25
USER INFORMATION
Kit BD BACTEC™ MGIT™ 960 PZA / manufacturer Becton Dickinson and Company, SUA
Ref. ANMDMR: 427/25
USER INFORMATION
FRED easyport / manufacturer SCHILLER AG, Elvetia
Ref. ANMDMR: 436/25
USER INFORMATION
N LATEX FLC LAMBDA/ manufacturer Siemens Healthcare Diagnostics Products GmbH, Germania
Ref. ANMDMR: 439/25
USER INFORMATION
Anti TPO Ab ELISA/ manufacturer DRG Instruments GmbH, Germania
Ref. ANMDMR: 440/25
USER INFORMATION
Cateter IV ecranat BD® Insyte™ Autoguard™ / manufacturer Becton Dickinson Infusion Therapy Systems Inc., SUA
Ref. ANMDMR: 441/25
USER INFORMATION
Aparat de curățat cu ultrasunete pentru răni – Curason / manufacturer Curasonix GmbH, Germania
Ref. ANMDMR: 446/25
PRODUCT RECALL
Ventilatoare : Newport™ HT70 și HT70 Plus / manufacturer Covidien LLC, SUA
Ref. ANMDMR: 450/25
USER INFORMATION
Consumabile MEDTRON AG / manufacturer MEDTRON AG, Germania
Ref. ANMDMR: 458/25
USER INFORMATION
Sistem MUSE 5 / manufacturer GE Medical Systems Information Technologies, Inc., SUA
Ref. ANMDMR: 459/25
PRODUCT RECALL
Extended Tip Applicator (XTA) / manufacturer Integra Lifesciences Corporation, SUA
Ref. ANMDMR: 463/25
USER INFORMATION
Allon® / manufacturer Belmont Medical Technologies, SUA
Ref. ANMDMR: 468/25
USER INFORMATION
Alinity i Total PSA Reagent Kit / manufacturer Abbott Ireland Diagnostics Division, Irlanda
Ref. ANMDMR: 471/25
USER INFORMATION
ORBIS Medication 3.x / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 472/25
USER INFORMATION
ORBIS Medication 3.x / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 473/25
USER INFORMATION
MUTARS® / manufacturer implantcast GmbH, Germania
Ref. ANMDMR: 475/25
USER INFORMATION
Masti oronazale NovaStar plus și Nova Star TS / manufacturer Drägerwerk AG & Co. KGaA, Germania
Ref. ANMDMR: 490/25
USER INFORMATION
Sisteme Philips Allura și Azurion / manufacturer Philips Medical Systems Nederland BV, Tările de Jos
Ref. ANMDMR: 494/25
PRODUCT RECALL
LIFEPEARL™ Drug Elutable Microspheres / manufacturer MicroVention Europe SARL, Franța
Ref. ANMDMR: 495/25
USER INFORMATION
Thyreoidal Peroxidase-Ab (TPO-Ab) / manufacturer Demeditec Diagnostics GmbH, Germania
Ref. ANMDMR: 498/25
USER INFORMATION
Dexcom ONE+ iOS CGM App / manufacturer Dexcom, Inc., SUA
Ref. ANMDMR: 500/25
USER INFORMATION
VITROS® 4600 Chemistry Systems și VITROS® 5600 and XT 7600 Integrated Systems / manufacturer QuidelOrtho (Ortho Clinical Diagnostics Inc), SUA
Ref. ANMDMR: 501/25
USER INFORMATION
428c / manufacturer
Ref. ANMDMR: 428c/25
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.