SUMMARY OF FIELD SAFETY NOTIFICATIONS / NOVEMBER 2025
USER INFORMATION
Componenta Q-link 13/ manufacturer Liko AB, Suedia
Ref. ANMDMR: 551/25
USER INFORMATION
Electrolyte Analyzer / manufacturer Roche Diagnostics GmbH, Germania
Ref. ANMDMR: 1519/25
USER INFORMATION
Bicarbonat / manufacturer Beckman Coulter Ireland Inc., Irlanda
Ref. ANMDMR: 1556/25
USER INFORMATION
Automated Impella Controller / manufacturer Abiomed Inc., SUA
Ref. ANMDMR: 1572/25
USER INFORMATION
Salte pneumatice terapeutice Accella / manufacturer Hillrom S.A.S., Franța
Ref. ANMDMR: 1573/25
USER INFORMATION
Kit BD BACTEC™ MGIT 960 PZA™ / manufacturer Becton Dickinson and Company, SUA
Ref. ANMDMR: 1574/25
USER INFORMATION
Sistemele Philips CT / manufacturer Philips Healthcare (Suzhou) Co., Ltd, China
Ref. ANMDMR: 1577/25
USER INFORMATION
Easy Pulse / manufacturer SCHILLER AG, Elveţia
Ref. ANMDMR: 1582/25
PRODUCT RECALL
Injekt® Luer Solo / manufacturer B.Braun Melsungen AG, Germania
Ref. ANMDMR: 1583/25
USER INFORMATION
Cardiosave Intra-Aortic Balloon Pumps / manufacturer Datascope Corp., SUA
Ref. ANMDMR: 1585/25
PRODUCT RECALL
ExtremiLock Ankle 7 Hole Right Anterolateral Tibia Plate / manufacturer OSTEOMED, LLC, SUA
Ref. ANMDMR: 1590/25
USER INFORMATION
IsoSeed / manufacturer Eckert & Ziegler BEBIG GmbH, Germania
Ref. ANMDMR: 1592/25
USER INFORMATION
Sisteme Zenition 10 și Zenition 30/ manufacturer Philips Medical Systems Nederland BV, Tările de Jos
Ref. ANMDMR: 1602/25
USER INFORMATION
Accelerator liniar digital / manufacturer Elekta Solutions AB, Suedia
Ref. ANMDMR: 1606/25
USER INFORMATION
Acului rotativ ZenFlex / manufacturer Kerr Italia S.r.l., Italia
Ref. ANMDMR: 1611/25
USER INFORMATION
Dräger Catheter Mounts ErgoStar CM 40, ErgoStar CM 45, ErgoStar CM 55, ErgoStar CM 60 / manufacturer Drägerwerk AG & Co. KGaA, Germania
Ref. ANMDMR: 1620/25
USER INFORMATION
Amnioquick Card Amnioquick Duo+ / manufacturer Biosynex SA, Franţa
Ref. ANMDMR: 1628/25
USER INFORMATION
Hand Files / manufacturer Kerr Italia S.r.l., Italia
Ref. ANMDMR: 1631/25
USER INFORMATION
Colour Coded Syringes / manufacturer MedNet GmbH, Germania
Ref. ANMDMR: 1634/25
USER INFORMATION
CGM CLINICAL Medication / manufacturer CompuGroup Medical Software GmbH, Germania
Ref. ANMDMR: 1646/25
USER INFORMATION
Vapor 2000 și Vapor 3000 / manufacturer Drägerwerk AG & Co. KGaA, Germania
Ref. ANMDMR: 1655/25
USER INFORMATION
Orbis Medication / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 1658/25
USER INFORMATION
Baterii / manufacturer Klaxon Mobility GmbH, Austria
Ref. ANMDMR: 1671/25
USER INFORMATION
Alinity ci-series System Control Module (SCM) / manufacturer Abbott Laboratories, SUA
Ref. ANMDMR: 1685/25
USER INFORMATION
Monitor de presiune intracraniană Pressio®2 / manufacturer SOPHYSA, Franţa
Ref. ANMDMR: 1687/25
USER INFORMATION
Elecsys Anti-TSHR assay / manufacturer Roche Diagnostics GmbH, Germania
Ref. ANMDMR: 1705/25
USER INFORMATION
Compoflow systems / manufacturer Fresenius Kabi AG, Germania
Ref. ANMDMR: 1737/25
USER INFORMATION
SunStim, SunStim Plus, SunStim Pro / manufacturer EasyMed Instruments Co., Ltd, China
Ref. ANMDMR: 1755/25
USER INFORMATION
Single use ligating device polyloop/ manufacturer Olympus Medical Systems Corporation, Germania
Ref. ANMDMR: 1759/25
USER INFORMATION
Monitoare pacienți Carescape B450, Carescape One / manufacturer GE Medical Systems Information Technologies, Inc., SUA
Ref. ANMDMR: 1761/25
USER INFORMATION
Ecografie ViewPointTM / manufacturer GE Healthcare GmbH, Germania
Ref. ANMDMR: 1775/25
USER INFORMATION
GBM Ab / manufacturer Demeditec Diagnostics GmbH, Germania
Ref. ANMDMR: 1782/25
USER INFORMATION
Anti-GBM / manufacturer ORGENTEC Diagnostika GmbH, Germania
Ref. ANMDMR: 1783/25
USER INFORMATION
Analizoare din seria ABL800 / manufacturer Radiometer Medical ApS, Danemarca
Ref. ANMDMR: 1789/25
USER INFORMATION
Vaporizator electronic V90 pentru utilizare cu sistemul de anestezie A9 / manufacturer Shenzhen Mindray Bio-Medical Electronics Co., Ltd., China
Ref. ANMDMR: 1791/25
USER INFORMATION
I-Mag Screen reagent/ manufacturer Diagast, Franța
Ref. ANMDMR: 1880/25
USER INFORMATION
Sistemele cu ultrasunete cu baterii Flex Focus, bkSpecto, bk3000, bk3500, bk5000 și bkActiv / manufacturer BK Medical Aps, Danemarca
Ref. ANMDMR: 1881/25
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.