SUMMARY OF FIELD SAFETY NOTIFICATIONS / MAY 2026
USER INFORMATION
Sistemele Philips RM / manufacturer Philips Medical Systems Nederland B.V., Olanda
Ref. ANMDMR: 419/25
USER INFORMATION
Sisteme Philips Allura și Azurion / manufacturer Philips Medical Systems Nederland BV
Ref. ANMDMR: 494/25
USER INFORMATION
Sistemele Philips RM / manufacturer Philips Medical Systems Nederland B.V., Olanda
Ref. ANMDMR: 594/25
USER INFORMATION
Depunere de aerosoli obținuți prin nebulizare pe senzorii de debit Trilogy Evo, Trilogy Evo O2, Trilogy EV300 / manufacturer Philips Respironics, Inc., SUA
Ref. ANMDMR: 647/26
USER INFORMATION
Test Thermo Fisher Scientific B·R·A·H·M·S PlGF Plus KRYPTOR / manufacturer B·R·A·HMS GmbH, Germania
Ref. ANMDMR: 724/26
USER INFORMATION
Toate dispozitivele BiPAP A30, BiPAP A30 Hybrid, BiPAP A40 și BiPAP A40 Pro / manufacturer Respironics Inc., SUA
Ref. ANMDMR: 845/26
USER INFORMATION
Navify® Digital Pathology v2.5 / manufacturer Ventana Medical Systems Inc., SUA
Ref. ANMDMR: 881/26
PRODUCT RECALL
Capete femurale ceramice LEC®plus și ELEC®plus Revision / manufacturer ARTIQO GmbH, Germania
Ref. ANMDMR: 905/26
PRODUCT RECALL
Cateter de ghidaj cu balon Bobby / manufacturer MicroVention, Inc., SUA
Ref. ANMDMR: 910/26
USER INFORMATION
Amplificator/înregistrator EEG / manufacturer Micromed S.p.A, Italia
Ref. ANMDMR: 927/26
USER INFORMATION
Software planificare implanturi și proiectare ghiduri chirurgicale exoplan / manufacturer exocad GmbH, Germania
Ref. ANMDMR: 931/26
USER INFORMATION
GETINGE 88-5 Washer Disinfector / manufacturer Getinge Disinfection AB, Suedia
Ref. ANMDMR: 936/25
PRODUCT RECALL
Multi-Snare® / manufacturer pfm medical mepro gmbh, Germania
Ref. ANMDMR: 966/26
USER INFORMATION
SX-ELLA Stent Danis (Stent Danis), Danis Procedure Pack – Basic,
Danis Procedure Pack / manufacturer ELLA-CS, s.r.o., Republica Cehă
Ref. ANMDMR: 969/26
USER INFORMATION
Stații de anestezie Dräger Atlan / manufacturer Drägerwerk AG & Co. KGaA, Germania
Ref. ANMDMR: 970/26
USER INFORMATION
CGM CLINICAL / manufacturer CompuGroup Medical Software GmbH, Germania
Ref. ANMDMR: 973/26
PRODUCT RECALL
Cardiohelp II / manufacturer Maquet Cardiopulmonary GmbH, Germania
Ref. ANMDMR: 975/26
USER INFORMATION
Sistemul da Vinci® 5 / manufacturer Intuitive Surgical, Inc., SUA
Ref. ANMDMR: 977/26
USER INFORMATION
Sistemele Philips Azurion / manufacturer Philips Medical Systems Nederland BV, Tarile de Jos
Ref. ANMDMR: 983/26
USER INFORMATION
Sisteme Philips Allura și Azurion / manufacturer Philips Medical Systems Nederland BV, Tarile de Jos
Ref. ANMDMR: 985/26
PRODUCT RECALL
Saw blade/ manufacturer newbox medical GmbH, Germania
Ref. ANMDMR: 990/26
USER INFORMATION
Adaptor pentru poziționarea capului/ manufacturer Baxter Medical Systems GmbH + Co. KG, Germania
Ref. ANMDMR: 991/26
USER INFORMATION
Sistemele Philips Azurion și Allura/ manufacturer Philips Medical Systems Nederland BV, Țările de Jos
Ref. ANMDMR: 993/26
USER INFORMATION
Zenition 10 și Zenition 30 / manufacturer Philips Medical Systems Nederland BV, Țările de Jos
Ref. ANMDMR: 994/26
USER INFORMATION
Știft de fixare a frânei electrice de pe carul pacientului / manufacturer Intuitive Surgical, Inc., SUA
Ref. ANMDMR: 1013/26
USER INFORMATION
Sistemul de Îngrijire a Pacienților (PCS) Merlin™ 3650 / manufacturer Abbott Medical, SUA
Ref. ANMDMR: 1015/26
PRODUCT RECALL
Stabilizator de țesuturi Octopus™/ manufacturer Medtronic, Inc., SUA
Ref. ANMDMR: 1017/26
USER INFORMATION
Sistem CASETM v7 / manufacturer GE Medical Systems Information Technologies, Inc.SUA
Ref. ANMDMR: 1024/26
PRODUCT RECALL
Recall due to microbial contamination of MANUSHIELD CLEANER/ manufacturer Dr. Schumacher GmbH, Germania
Ref. ANMDMR: 1029/26
USER INFORMATION
Sisteme Allia IGS / manufacturer GE Medical Systems SCS, Franța
Ref. ANMDMR: 1036/26
USER INFORMATION
Mănuși pentru examinare medicala / manufacturer Reflexx SPA, Italia
Ref. ANMDMR: 1039/26
PRODUCT RECALL
Produsele ViaCath NG 4/S/5mm and ViaCath 20/XL/2-8-2mm / manufacturer VascoMed GmbH, Germania
Ref. ANMDMR: 1053/26
USER INFORMATION
Orbis Medication / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 1070/26
USER INFORMATION
Defibrilator extern automatBeneHeart D1 / manufacturer Shenzhen Mindray Bio-Medical Electronics Co., Ltd., China
Ref. ANMDMR: 1079/26
USER INFORMATION
Electrocardiograf portabil / manufacturer Suzhou Beneware Medical Equipment Co., Ltd. China
Ref. ANMDMR: 1085/26
PRODUCT RECALL
Șurub canulat de compresie pentru osteosinteză 5.0 headedCCS Long Thread 50/20mm, 1/Pkg (A-8216.50/1) / manufacturer Medartis AG, Elevetia
Ref. ANMDMR: 1086/26
USER INFORMATION
Actualizare firmware pentru panoul detectorului sistemului de imagistică O2 O-arm™ / manufacturer Medtronic Navigation, Inc., SUA
Ref. ANMDMR: 1089/26
USER INFORMATION
Produsul OncomineTM Dx Express Test Panel / manufacturer Life Technologies Corporation, SUA
Ref. ANMDMR: 1092/26
USER INFORMATION
Cuțit microchirurgical Sharpoint / manufacturer Surgical Specialties Mexico S. DE R.L. DE C.V., Mexic
Ref. ANMDMR: 1094/26
PRODUCT RECALL
Canulă Priflex® / manufacturer Primed Halberstadt Medizintechnik GmbH, Germania
Ref. ANMDMR: 1096/26
USER INFORMATION
Robinete BD Connecta™ / manufacturer BD Switzerland Sàrl, Elvetia
Ref. ANMDMR: 1100/26
USER INFORMATION
Dispozitivele Giraffe OmniBed și Giraffe OmniBed Carestation/ manufacturer Datex-Ohmeda, Inc., SUA
Ref. ANMDMR: 1101/26
USER INFORMATION
Server de telemetrie ApexPro CARESCAPE v5.0 și v6.0 cu stația centrală CARESCAPE sau Centrul de informații clinice CIC Pro / manufacturer GE Medical Systems Information Technologies, Inc., SUA
Ref. ANMDMR: 1102/26
USER INFORMATION
Produs AW Server 3.2 ext. 6.5/ manufacturer GE Medical Systems SCS, SUA
Ref. ANMDMR: 1103/26
USER INFORMATION
Sistem ARTIS icono / manufacturer Siemens Healthcare GmbH, Germania
Ref. ANMDMR: 1112/26
USER INFORMATION
Set de circuit respirator coaxial / manufacturer Hamilton Medical AG, Elvetia
Ref. ANMDMR: 1113/26
USER INFORMATION
Catetere de dilatare cu balon / manufacturer Boston Scientific Corporation, SUA
Ref. ANMDMR: 1121/26
USER INFORMATION
APL valve/ manufacturer Armstrong Medical Ltd, Marea Britanie
Ref. ANMDMR: 1125/26
USER INFORMATION
Sistem Philips Allura Xper, Allura CV20 și Allura Centron / manufacturer Philips Medical Systems Nederland BV, Tarile de Jos
Ref. ANMDMR: 1131/26
USER INFORMATION/
Ventilator terapie intensivă elisa / manufacturer Löwenstein Medical Innovation GmbH & Co. KG, Germania
Ref. ANMDMR: 1141/26
PRODUCT RECALL
Sistem de poziționare cu cateter Harmony™ / manufacturer Medtronic, Inc., SUA
Ref. ANMDMR: 1142/26
USER INFORMATION
Sistem automat de administrare a radiofarmaceuticelor IRIS / manufacturer Comecer Netherlands B.V., Tarile de Jos
Ref. ANMDMR: 1145/26
USER INFORMATION
Sistem radiologie intervențională / manufacturer Canon Inc., Japonia
Ref. ANMDMR: 1158/26
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.