SUMMARY OF FIELD SAFETY NOTIFICATIONS / AUGUST 2024
USER INFORMATION
BiPAP A30, BiPAP A30 EFL, BiPAP A30 Hybrid, BiPAP A40, BiPAP A40 EFL, BiPAP A40 Pro / manufacturer Respironics, Inc., SUA
Ref. NAMMDR: 302.227/24
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Samsung Digital Diagnostic Mobile X-ray System/ manufacturer Samsung Electronics Co., Limited, Coreea
Ref. NAMMDR: 304.345/24
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MobileDiagnost wDR / manufacturer Philips Medical Systems DMC GmbH, Germania
Ref. NAMMDR: 304.355/24
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Flow Cytometer / manufacturer Sysmex Corporation Japan, Japonia
Ref. NAMMDR: 304.738/24
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HeartStart Intrepid Monitor/Defibrillator display intermittent ECG waveforms/ manufacturer Philips Goldway (Shenzhen) Industrial Inc., China
Ref. NAMMDR: 304.744/24
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PST 500 U Precision Surgical Table / manufacturer Baxter Medical Systems GmbH + Co. KG, Germania
Ref. NAMMDR: 304.746/24
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Sistem radiografic de uz general Proteus XR/a / manufacturer GE Hualun Medical Systems Co. Ltd, China
Ref. NAMMDR: 304.747/24
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Arm support for display wall suspension – Luminos Agile/dRF/Lotus Max, Multitom Rax / manufacturer Siemens Healthcare GmbH, Germania
Ref. NAMMDR: 304.748/24
USER INFORMATION
Incorrect Software Options for Philips lntelliVue Patient Monitors MX400/450/500/550 / manufacturer Philips Medizin Systeme Böblingen GmbH, Germania
Ref. NAMMDR: 304.750/24
PRODUCT RECALL
WallFlexTM – Sistem de stent esofagian, AgileTM – Sistem de stent esofagian cu fir / manufacturer Boston Scientific Corporation, SUA
Ref. NAMMDR: 304.751/24
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Spaceplus Infusomat® – Wave Spring / manufacturer B.Braun Melsungen AG, Germania
Ref. NAMMDR: 304.858/24
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Papenzyme Plus / manufacturer Lorne Laboratories Ltd., Marea Britanie
Ref. NAMMDR: 304.859/24
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Monitorul/defibrilatorul HeartStart Intrepid – Forma de undă EKG intermitente / manufacturer Philips Goldway (Shenzhen) Industrial Inc., China
Ref. NAMMDR: 304.872/24
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Multi-Socket Strip / manufacturer MTG Medizinisch-Technische Gerätebau GmbH, Germania
Ref. NAMMDR: 304.899/24
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Olympus EndoDis Pro / manufacturer Ecolab Deutschland GmbH, Germania
Ref. NAMMDR: 304.900/24
PRODUCT RECALL
Rite Aid Hydrogel Breast Discs 12pk / manufacturer ToLife Technologies Pty Ltd, Australia
Ref. NAMMDR: 304.901/24
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Dental drill / manufacturer Acurata GmbH & Co. KGaA, Germania
Ref. NAMMDR: 304.907/24
PRODUCT RECALL
MONOPLUS®, MONOSYN®, NOVOSYN®, NOVOSYN® CHD / manufacturer B. Braun Surgical, S.A., Spania
Ref. NAMMDR: 304.908/24
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Ventilatoare LUISA, TIVAN LS, Life One/ manufacturer Löwenstein Medical Technology GmbH + Co. KG, Germania
Ref. NAMMDR: 304.909/24
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Alinity hq Analyzer / manufacturer Abbott Laboratories, SUA
Ref. NAMMDR: 304.910/24
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Aparate de anestezie – Aisys CS2, Avance CS2, Avance CS2 Pro, Aisys, Avance, Amingo, Aespire 100, Aespire View, Aespire 7900 și Aespire 7100 configurate cu ieșire de gaz comună auxiliară / manufacturer Datex-Ohmeda, Inc., SUA
Ref. NAMMDR: 304.980/24
USER INFORMATION/ PRODUCT RECALL
Lentile de contact Alcon DAILIES TOTAL1® și TOTAL30® / manufacturer Alcon Laboratories, Inc., SUA
Ref. NAMMDR: 304.988/24
PRODUCT RECALL
Forehead Reamer / manufacturer Unintech GmbH, Germania
Ref. NAMMDR: 304.989/24
PRODUCT RECALL
Custom Tubing Packs (CTP) / manufacturer Maquet Cardiopulmonary GmbH, Germania
Ref. NAMMDR: 305.054/24
PRODUCT RECALL
Salivary Testosterone ELISA / manufacturer DRG Instruments GmbH, Germania
Ref. NAMMDR: 305.055/24
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HD Lightweight Pendulum Camera Head / manufacturer Olympus Medical Systems Corporation, Japonia
Ref. NAMMDR: 305.056/24
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Sistemul Philips Azurion R1.x / manufacturer Philips Medical Systems Nederland BV, Olanda
Ref. NAMMDR: 305.058/24
PRODUCT RECALL
1.2 K-Wire, Lancet, 150mm / manufacturer Medartis AG, Elveția
Ref. NAMMDR: 305.060/24
PRODUCT RECALL
REGENETEN Tendon Anchors / manufacturer Smith & Nephew, Inc., SUA
Ref. NAMMDR: 305.106/24
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VENTANA anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody / manufacturer Ventana Medical Systems Inc, SUA
Ref. NAMMDR: 305.107/24
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High flow insufflation unit / manufacturer Olympus Medical Systems Corporation, Japonia
Ref. NAMMDR: 305.110/24
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ORBIS Medication 3.x / manufacturer DH Healthcare GmbH, Germania
Ref. NAMMDR: 305.116/24
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Serial interface cable (RS232) for Rotaflow II System / manufacturer Maquet Cardiopulmonary GmbH, Germania
Ref. NAMMDR: 305.117/24
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Marodyne-LiV / manufacturer BTT Health GmbH, Germania
Ref. NAMMDR: 305.124/24
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Fluido® Trauma set 671500/ Fluido® Standard set 671200 / manufacturer The Surgical Company International BV
Ref. NAMMDR: 305.126/24
USER INFORMATION
Heart pump : Impella 5.5 with SmartAssist and Impella CP with SmartAssist / manufacturer Abiomed Inc., SUA
Ref. NAMMDR: 305.128/24
PRODUCT RECALL
Multicath2 / manufacturer VYGON GmbH & Co. KG, Germania
Ref. NAMMDR: 305.226/24
USER INFORMATION
DeepUnity Diagnost (all versions) / manufacturer DH Healthcare GmbH, Germania
Ref. NAMMDR: 305.228/24
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DeepUnity Viewer (all versions) / manufacturer DH Healthcare GmbH, Germania
Ref. NAMMDR: 305.229/24
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Vanta™ Implantable Neurostimulator / manufacturer Medtronic Inc., SUA
Ref. NAMMDR: 305.231/24
USER INFORMATION
Battery corpuls cpr (LiPo) / manufacturer GS Elektromedizinische Geräte G. Stemple GmbH, Germania
Ref. NAMMDR: 305.232/24
PRODUCT RECALL
HLM Tubing Set / manufacturer Maquet Cardiopulmonary GmbH, Germania
Ref. NAMMDR: 305.234/24
USER INFORMATION
Azurion 7M20 cu stativ FlexArm / manufacturer Philips Medical Systems Nederland BV, Olanda
Ref. NAMMDR: 305.264/24
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Trilogy Evo, Trilogy Evo O2 şi Trilogy EV300 / manufacturer Philips Respironics, Inc., SUA
Ref. NAMMDR: 305.265/24
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Actualizare software – StealthStation™ S8 / manufacturer Medtronic Navigation Inc., SUA
Ref. NAMMDR: 305.320/24
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Alinity i HBsAg Controls, ARCHITECT HBsAg Controls / manufacturer Abbott Ireland Diagnostics Division, Irlanda
Ref. NAMMDR: 305.321/24
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Ortho DataVue System / manufacturer BECOM Software AG, Germania
Ref. NAMMDR: 305.326/24
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Ventilatoare Sophie și Sophie 2020/ manufacturer Fritz Stephan GmbH, Germania
Ref. NAMMDR: 305.329/24
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Husă detașabilă de recuperare Endo / manufacturer Unimax Medical Systems, Inc., Taiwan
Ref. NAMMDR: 305.385/24
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Analizoare ACL TOP Family și ACL TOP Family Seria 50 / manufacturer Instrumentation laboratory Co., SUA
Ref. NAMMDR: 306.020/24
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.