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16.12.2025
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Urgent Field Safety Notice for Head Fixation Device- HFD100 by Deerfield Imaging, Inc.
Product group Surgical equipment/ Anaesthesia -
surgical equipment
Reference 60228/25
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16.12.2025
|
Urgent Field Safety Notice for ArTT - Trial Phantom Buttress by LIMACORPORATE S.P.A.
Product group Medical instruments for use in humans -
bone surgery
Reference 58021/25
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|
16.12.2025
|
Direct Healthcare Professional Communication (DHPC) on melphalan hydrochloride, Melphalan AqVida 90 mg/ml concentrate for solution for infusion: potential risk of overdose due to higher concentration
Active substance: melphalan hydrochloride
AqVida GmbH would like to inform you that Melphalan AqVida 90 mg/ml is a melphalan formulation that is supplied in a single vial.
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15.12.2025
|
Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH
Product group Medical data processing (software) -
others
Reference 58390/25
|
|
15.12.2025
|
Urgent Field Safety Notice for IntelliVue Patient Monitor by Philips Medizin Systeme Böblingen GmbH
Product group Medical electronics / Electromedical devices -
electrodiagnostics
Reference 52075/25
|
|
15.12.2025
|
Urgent Field Safety Notice for Photodynamic Therapy Device by Xuzhou Kernel Medical Equipment Co., Ltd.
Product group Optics / Precision engineering -
others
Reference 56870/25
|
|
15.12.2025
|
Events and trainings
Events and trainings
|
|
15.12.2025
|
Updated information Iris Webinar - January 2026
Updated information Iris Webinar - January 2026
|
|
15.12.2025
|
NEW CONTENT, ISSUE 12.2
NEW CONTENT, ISSUE 12.2
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12.12.2025
|
Oxbryta (voxelotor): Review of the benefit-risk ratio
Active substance: voxelotor
With the publication of the European Commission's decision on 9 December 2025, the risk assessment procedure for Oxbryta (voxelotor) was completed.
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12.12.2025
|
Urgent Field Safety Notice for Carestation 600 and 700 Series by Datex-Ohmeda, Inc.
Product group Surgical equipment/ Anaesthesia -
anaesthesia and medical gas supply
Reference 58778/25
|
|
12.12.2025
|
Urgent Field Safety Notice for DECALCIFIER DC1 Slow-acting Q PATH 5 L, FORMALIN 10% BUFFERED Q PATH(R) CUBI by VWR International SAS
Product group In-vitro diagnostics -
haematological, histological and cytological products
Reference 56721/25
|
|
12.12.2025
|
Urgent Field Safety Notice for FlexLab X by Inpeco SA
Product group In-vitro diagnostics -
instruments, apparatuses and systems
Reference 52059/25
|
|
11.12.2025
|
Urgent Field Safety Notice for da Vinci Xi and da Vinci X Surgical System by Intuitive Surgical, Inc
Product group Surgical equipment/ Anaesthesia -
surgical equipment
Reference 53565/25
|
|
11.12.2025
|
Urgent Field Safety Notice for IsoSeed I25.S16 by Eckert & Ziegler BEBIG GmbH
Product group Active implantable medical devices -
implantats emitting radioactive radiation
Reference 58876/25
|
|
11.12.2025
|
Direct Healthcare Professional Communication (DHPC) on intravenous tranexamic acid formulations: Serious, including fatal, adverse reactions due to accidental intrathecal administration
Active substance: tranexamic acid
The marketing authorisation holders inform that injectable tranexamic acid formulations are only authorised for intravenous use.
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|
10.12.2025
|
Urgent Field Safety Notice for Incisive CT, CT 5300 by Philips Healthcare (Suzhou) Co.,Ltd
Product group Radiological technology -
CT scanners
Reference 56698/25
|
|
10.12.2025
|
Urgent Field Safety Notice for Synthes Cutting Tools by Synthes GmbH
Product group Medical instruments for use in humans -
bone surgery
Reference 57313/25
|
|
09.12.2025
|
Urgent Field Safety Notice for EVER Pharma D-mine Pump Reservoir by Ever Neuro Pharma GmbH
Product group Injections / Infusions / Transfusions / Dialysis -
infusion technology
Reference 57196/25
|
|
09.12.2025
|
Urgent Field Safety Notice for Farbkodierte Spritze, 10 ml, LL, Polycarbonat, rot und blau enthalten im OP-Set by Medline International France SAS
Product group Injections / Infusions / Transfusions / Dialysis -
syringes and cannulas
Reference 56186/25
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