SUMMARY OF FIELD SAFETY NOTIFICATIONS / JULY 2026
PRODUCT RECALL
Dispozitive medicale A.T.S.® 5000TS and A.T.S.® 3200TS Tourniquet Systems / manufacturer Zimmer Surgical, Inc., SUA
Ref. ANMDMR: 92/26
USER INFORMATION
Laringoscop video / manufacturer Remote Diagnostic Technologies Ltd., GB
Ref. ANMDMR: 308/25
USER INFORMATION
Un kit de analiză a mutațiilor EGFR din ctDNA/ manufacturer EntroGen Inc., SUA
Ref. ANMDMR: 1274/26
USER INFORMATION
Sistemul de depărtătoare chirurgicale Integra® Omni-Tract / manufacturer Integra Lifesciences Corporation, SUA
Ref. ANMDMR: 1279/26
USER INFORMATION
Umidificator cu bule / manufacturer Hsiner, Taiwan
Ref. ANMDMR: 1359/26
USER INFORMATION
BD Connecta Stopcocks / manufacturer Lohmann & Rauscher International, Germania
Ref. ANMDMR: 1387/26
USER INFORMATION
Dispozitive pentru anestezie Flow-i / manufacturer Maquet Critical Care AB, Suedia
Ref. ANMDMR: 1399/26
USER INFORMATION
Dispozitive de programare Medtronic CareLink™ 2090 și CareLink™ Encore 29901/ manufacturer Medtronic Inc., SUA
Ref. ANMDMR: 1400/26
PRODUCT RECALL
Implanturi pentru articulația temporomandibulară / manufacturer TMJ Solutions, LLC dba TMJ Concepts, SUA
Ref. ANMDMR: 1416/26
PRODUCT RECALL
Produse pentru sutură Surgipro™, Surgipro II™, Dermalon™, V-Loc™ 90 și V-Loc™ 18029901 / manufacturer Covidien llc, SUA
Ref. ANMDMR: 1433/26
USER INFORMATION
Mașini de spălat și dezinfectat automate (WD) +Soluscope Serie 4 și Serie 1 / manufacturer Soluscope SAS, Franta
Ref. ANMDMR: 1434/26
USER INFORMATION
Silver Graft / manufacturer Aesculap AG, Germania
Ref. ANMDMR: 1452/26
PRODUCT RECALL
Dispozitiv pentru perfuzie / manufacturer BQ Plus Medical Co., Ltd., China
Ref. ANMDMR: 1455/26
PRODUCT RECALL
Fibre laser chirurgicale / manufacturer KLS Martin SE & Co. KG, Germania
Ref. ANMDMR: 1457/26
USER INFORMATION
Sterilizaor Getinge Poladus 150 H1/H2 / manufacturer MAQUET GmbH, Germania
Ref. ANMDMR: 1469/26
USER INFORMATION
Ventilatoare din familia EVE și Oxylog 600 / manufacturer Fritz Stephan GmbH, Germania
Ref. ANMDMR: 1473/26
USER INFORMATION
Cartușul de senzori pentru Cobas b 123 / manufacturer Roche Diagnostics GmbH, Germania
Ref. ANMDMR: 1474/26
PRODUCT RECALL
Dispozitive OverStitch™ Suture Cinch și Suture Cinch–Long / manufacturer Boston Scientific Corporation, SUA
Ref. ANMDMR: 1484/26
USER INFORMATION
Set de perfuzie de unică folosinţă BD® neXus / manufacturer Medcaptain Life Science Co., Ltd., China
Ref. ANMDMR: 1487/26
PRODUCT RECALL
Set tuburi personalizate (CTPs) / manufacturer Maquet Cardiopulmonary GmbH, Germania
Ref. ANMDMR: 1489/26
PRODUCT RECALL
Catetere uretrale Onli™ și Infyna™ / manufacturer Hollister Incorporated, SUA
Ref. ANMDMR: 1491/26
USER INFORMATION
Automated Impella Controller (AIC) / manufacturer Abiomed Inc., SUA
Ref. ANMDMR: 1505/26
USER INFORMATION
Dispozitiv medical pentru menținerea temperaturii Heater Unit HU 35 / manufacturer Maquet Cardiopulmonary GmbH, Germania
Ref. ANMDMR: 1509/26
PRODUCT RECALL
Cateter venos lifecath CT PICC easy / manufacturer Vygon Germany GmbH, Germania
Ref. ANMDMR: 1512/26
USER INFORMATION
Concentrator de oxigen Kröber O2 / manufacturer Kröber Medizintechnik GmbH, Germania
Ref. ANMDMR: 1520/26
PRODUCT RECALL
Rampa de robineti Angiodyn Manifold 3 FRR 35BAR / manufacturer B. Braun Melsungen AG, Germania
Ref. ANMDMR: 1529/26
USER INFORMATION
Implanturi cardiace Figulla Flex II ASD Occluder / manufacturer Occlutech GmbH, Germania
Ref. ANMDMR: 1536/26
PRODUCT RECALL
Cateter cu balon OPN NC 400-015-004 / manufacturer SIS Medical AG, Elvetia
Ref. ANMDMR: 1540/26
USER INFORMATION
Monitor pentru pacienți / manufacturer Shenzhen Mindray Bio-Medical Electronics Co., Ltd., China
Ref. ANMDMR: 1546/26
USER INFORMATION
Seturile de introducere Abiomed Impella 14 Fr și 23 Fr/ manufacturer Oscor Inc., SUA
Ref. ANMDMR: 1551/26
USER INFORMATION
Seturi de introducere Abiomed Impella 14 Fr și 23 Fr / manufacturer Oscor Inc., SUA
Ref. ANMDMR: 1552/26
USER INFORMATION
Analizor de chimie clinică DxC 500 AU / manufacturer Beckman Coulter Inc, SUA
Ref. ANMDMR: 1561/26
USER INFORMATION
Automated Impella Controller (AIC) / manufacturer Abiomed Inc., SUA
Ref. ANMDMR: 1564/26
USER INFORMATION
Set pentru administrare intravenoasă prin gravitație / manufacturer ICU Medical Inc, SUA
Ref. ANMDMR: 1565/26
USER INFORMATION
Sistem de management al medicației ORBIS Medication / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 1566/26
USER INFORMATION
Dispozitive cardiografie Cardiac Workstation 5000 și 7000 / manufacturer Philips Medizin Systeme Böblingen GmbH, Germania
Ref. ANMDMR: 1574/26
USER INFORMATION
Familia de ventilatoare EVE / manufacturer Fritz Stephan GmbH, Germania
Ref. ANMDMR: 1576/26
USER INFORMATION
Anti-Spermatozoa Antibody (ASA) serum ELISA / manufacturer Demeditec Diagnostics GmbH, Germania
Ref. ANMDMR: 1599/26
USER INFORMATION
Sistem de management al medicației ORBIS Medication / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 1607/26
USER INFORMATION
Sistem Munevo Drive / manufacturer Munevo GmbH, Germania
Ref. ANMDMR: 1620/26
USER INFORMATION
Dispozitiv medical E-motion M25 product / manufacturer Alber GmbH, Germania
Ref. ANMDMR: 1621/26
USER INFORMATION
Dispozitiv Spectralis® / manufacturer Heidelberg Engineering GmbH, Germania
Ref. ANMDMR: 1625/26
USER INFORMATION
Sisteme Philips Azurion R3.1 / manufacturer Philips Medical Systems Nederland BV, Tarile de Jos
Ref. ANMDMR: 1628/26
USER INFORMATION
Artis icono ceiling / manufacturer Siemens Healthcare GmbH, Germania
Ref. ANMDMR: 1630/26
PRODUCT RECALL
Tub Endotraheal Cu Balonaș / manufacturer Zarys International sp. z o.o, Polonia
Ref. ANMDMR: 1631/26
USER INFORMATION
Kit de inserție / manufacturer Maquet Cardiopulmonary GmbH, Germania
Ref. ANMDMR: 1632/26
PRODUCT RECALL
Seturile Medline Soft Liner / manufacturer Medline Industries, LP, SUA
Ref. ANMDMR: 1633/26
PRODUCT RECALL
Set perfuzie Beroset® / manufacturer Beromed GmbH Hospital Products, Geermania
Ref. ANMDMR: 1655/26
PRODUCT RECALL
Catetere venoase centrale Certofix protect / manufacturer B Braun Melsungen AG, Germania
Ref. ANMDMR: 1676/26
USER INFORMATION
Analizor Cobas / manufacturer Roche Diagnostics GmbH, Germania
Ref. ANMDMR: 1683/26
PRODUCT RECALL
Adaptor urologic Ialuadapter® / UroDapter® / manufacturer Pharmico Medical Kft, Ungaria
Ref. ANMDMR: 1688/26
USER INFORMATION
Ventilatoare neonatale medin-NC3 / manufacturer medin Medical Innovation GmbH, Germania
Ref. ANMDMR: 1691/26
USER INFORMATION
Sisteme Philips Azurion R3.1 / manufacturer Philips Medical Systems Nederland BV, Tarile de Jos
Ref. ANMDMR: 2033/26
USER INFORMATION
Sisteme Philips Azurion R2.1.10 și R2.2.10 / manufacturer Philips Medical Systems Nederland BV, Tarile de Jos
Ref. ANMDMR: 2034/26
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.