SUMMARY OF FIELD SAFETY NOTIFICATIONS / APRIL 2024
USER INFORMATION
Trilogy Evo, Trilogy Evo O2, Trilogy EV300 / manufacturer Philips Respironics Inc., SUA
Ref. ANMDMR: 301.607/24
USER INFORMATION
MR Systems / manufacturer Philips Healthcare, Olanda
Ref. ANMDMR: 301.987/24
PRODUCT RECALL
Airvo 2 Humidifier, myAirvo 2 Humidifier / manufacturer Fisher & Paykel Healthcare Ltd., Noua Zeelanda
Ref. ANMDMR: 301.989/24
PRODUCT RECALL
LASER Application Instrument 23 cm, LEUNIG-GREVERS LASER Application / manufacturer KARL STORZ SE & Co. KG, Germania
Ref. ANMDMR: 301.990/24
USER INFORMATION
BÜHLMANN GanglioCombi® MAG ELISA / manufacturer BÜHLMANN Laboratories AG, Elvetia
Ref. ANMDMR: 301.991/24
USER INFORMATION
Calibration Serum Level 3 / manufacturer Randox Laboratories Ltd., Marea Britanie
Ref. ANMDMR: 301.994/24
PRODUCT RECALL
VACSIII 22×40 Percutaneous Transluminal Valvuloplasty Catheter / manufacturer OSYPKA AG, Germania
Ref. ANMDMR: 302.043/24
USER INFORMATION
Trilogy Evo, Trilogy Evo 02, Trilogy Evo Universal, Trilogy EV300 / manufacturer Philips Respironics, Inc., SUA
Ref. ANMDMR: 302.044/24
USER INFORMATION
Trilogy Evo O2, Trilogy Evo Universal, Trilogy EV300 / manufacturer Philips Respironics, Inc., SUA
Ref. ANMDMR: 302.045/24
USER INFORMATION
Kit tampon pentru Clisis Systems, EIDOS RF439, Discovery RF180 / manufacturer General Medical Merate S.p.A., Italia
Ref. ANMDMR: 302.049/24
PRODUCT RECALL
Pressio® ventricular tunnelling catheter kit: PSO-VT, PSO-VTT / manufacturer SOPHYSA, Franta
Ref. ANMDMR: 302.120/24
USER INFORMATION
Evidence MultiSTAT / manufacturer Randox Laboratories Ltd., Marea Britanie
Ref. ANMDMR: 302.121/24
USER INFORMATION
Tempus LS / manufacturer SCHILLER AG, Elvetia
Ref. ANMDMR: 302.165/24
PRODUCT RECALL
Radialis Needle Arrow® QuickFlash® Radial Artery Catheterization Kit / manufacturer Arrow International LLC Subsidiary of Teleflex Incorporated, SUA
Ref. ANMDMR: 302.166/24
USER INFORMATION
BiPAP A30, BiPAP A30 EFL, BiPAP A30 Hybrid, BiPAP A40, BiPAP A40 EFL, BiPAP A40 Pro / manufacturer Respironics, Inc., SUA
Ref. ANMDMR: 302.227/24
USER INFORMATION
CARDIOHELP-i / manufacturer Maquet Cardiopulmonary GmbH, Germania
Ref. ANMDMR: 302.228/24
USER INFORMATION
ORBIS Medication / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 302.233/24
USER INFORMATION
Trilogy Evo, Trilogy Evo O2, Trilogy EV300 / manufacturer Respironics, Inc. Pittsburgh, SUA
Ref. ANMDMR: 302.274/24
USER INFORMATION
Tub de traheotomie din PVC siliconizat Portex ™ Blue Line / manufacturer Smiths Medical, SUA
Ref. ANMDMR: 302.423/24
PRODUCT RECALL
Bipolar Pacing Catheter Spike Flow / manufacturer Bioptimal International PTE. LTD., Singapore
Ref. ANMDMR: 302.444/24
PRODUCT RECALL
Exactech Optetrak Patella / manufacturer Exactech, Inc., SUA
Ref. ANMDMR: 302.464/24
USER INFORMATION
DeepUnity Diagnost / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 302.529/24
USER INFORMATION
HistoCore Pegasus, HistoCore Pegasus Plus Systems / manufacturer Leica Biosystems Nussloch GmbH, Germania
Ref. ANMDMR: 302.530/24
USER INFORMATION
Sursa de alimentare neintreruptibila (UPS) a Patient Information Center (PIC) iX / manufacturer Philips Medical Systems, SUA
Ref. ANMDMR: 302.540/24
PRODUCT RECALL
HeartSine® Samaritan® PAD 350P/360P/450P/500P, Omron HDF-3500 / manufacturer HeartSine Technologies, Ltd. (Stryker Medical), Marea Britanie
Ref. ANMDMR: 302.541/24
USER INFORMATION
Sisteme ecografice seria 5000 Compact / manufacturer Philips Ultrasound, LLC, SUA
Ref. ANMDMR: 302.542/24
USER INFORMATION
Aplicația StealthStation™ S8 / manufacturer Medtronic Navigation Inc., SUA
Ref. ANMDMR: 302.548/24
USER INFORMATION
Masks with magnets: Mojo, Mojo 2, iQ 2 and Phantom 2 / manufacturer Sleepnet Corporation, SUA
Ref. ANMDMR: 302.549/24
PRODUCT RECALL
VITELENE INSERT F 32MM POST.WALL, VITELENE INSERT F 36MM POST.WALL / manufacturer Aesculap AG, Germania
Ref. ANMDMR: 302.550/24
USER INFORMATION
ProBP 3400, Spot Vision Screener and Power Cords / manufacturer Welch Allyn, Inc., SUA
Ref. ANMDMR: 302.555/24
USER INFORMATION
Heart pumps: Impella 5.5 SmartAssist; Impella CP SmartAssist; Impella CP; Impella RP; Impella 5.0; Impella LD, Impella 2.5 / manufacturer Abiomed Inc., SUA
Ref. ANMDMR: 302.556/24
USER INFORMATION
CliniMACS Prodigy TS 310 / manufacturer Miltenyi Biotec B.V. & Co. KG, Germania
Ref. ANMDMR: 302.557/24
PRODUCT RECALL
HUMAN HumaMeter A1c Reagent Kit / manufacturer Human Gesellschaft für Biochemica und Diagnostica mbH, Germania
Ref. ANMDMR: 302.579/24
USER INFORMATION
D-Dimer Calibration Set / manufacturer Thermo Fisher Scientific Oy, Finlanda
Ref. ANMDMR: 302.582/24
USER INFORMATION
fabian™ HFO / manufacturer Acutronic Medical Systems AG, Elveția
Ref. ANMDMR: 302.584/24
PRODUCT RECALL
Electrosurgical Electrode / manufacturer Dongguan QueenMed Equipment Mfg Co. Ltd., China
Ref. ANMDMR: 302.589/24
USER INFORMATION
Various Mapleson F Anaesthetic Breathing Systems / manufacturer Intersurgical Ltd., Marea Britanie
Ref. ANMDMR: 302.590/24
PRODUCT RECALL
Affinis Inverse Drill-bit 2.5, Gen2; Affinis Inverse Drill-bit 3.2, Gen2 / manufacturer Mathys AG Bettlach, Elveția
Ref. ANMDMR: 302.591/24
USER INFORMATION
CGM CLINICAL Medication / manufacturer CompuGroup Medical Software GmbH, Germania
Ref. ANMDMR: 302.594/24
USER INFORMATION
Vaporizer Sevoflurane Maquet filling, Vaporizer Sevoflurane SAFE-T-SEAL, Vaporizer Sevoflurane Quik-Fil / manufacturer Maquet Critical Care AB, Suedia
Ref. ANMDMR: 302.603/24
USER INFORMATION
Sistemul Incisive CT/CT 3500/CT 5300 / manufacturer Philips Healthcare (Suzhou) Co., Ltd, China
Ref. ANMDMR: 302.607/24
USER INFORMATION
CGM CLINICAL Medication / manufacturer CompuGroup Medical Software GmbH, Germania
Ref. ANMDMR: 302.612/24
PRODUCT RECALL
EVOLUX / manufacturer SIFI S.p.A, Italia
Ref. ANMDMR: 302.615/24
USER INFORMATION
DuoLys kit / manufacturer DIAGAST, Franta
Ref. ANMDMR: 302.848/24
USER INFORMATION
ABD-Lys kit / manufacturer DIAGAST, Franta
Ref. ANMDMR: 302.849/24
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.