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News

List of recalls

Publication of safety measures (FSCA)

fsca.swissmedic.ch

Warnings and counterfeits

28.11.2018

Sicherheitsmitteilung: Duschstuhl / Duschhocker Aquatec Sorrento

Beinfixierung am Sitz der Firma Aquatec Operations GmbH

03.08.2018

Safety notice: Recall of three varieties of latex-free condoms – Durex Natural Feeling (pack of 10 condoms), Durex Love Collection (pack of 31 condoms) and Durex Natural Feeling Easy Glide (pack of 12 condoms) – produced by Reckitt Benckiser Healthcare (UK) Limited

09.07.2018

Safety Notice: Treatment couches with a MAX60 motor

MAX60 motor series: Mahe E, MAUI E, SAMOA E, SAMOA EE, BALI E, GOZO E1 - E3, Vojta Bobath E by the company Physioline GmbH - The electrically adjustable treatment couches, which are older than 10 years, can sag uncontrollably down

Announcements

29.05.2019

Events concerning medical devices

Events with speakers from Swissmedic

06.05.2019

Withdrawal of products indicated for transvaginal placement of pelvic organ prolapse produced by Boston Scientific Corporation

16.04.2019

Treatment of peripheral arterial disease with paclitaxel-coated balloons and paclitaxel-eluting stents

Potential association with increased mortality

05.04.2019

Breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) – updated information

Swissmedic statement

01.04.2019

Discontinuation of sale of mesh produced by C.R. Bard, Inc. for pelvic organ prolapse and stress urinary incontinence, and its removal from hospitals and distribution centres

18.02.2019

Breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) – updated information

Updated PDF forms

30.04.2019

BW510_00_003e_FO Clinical trials of research sequences on CE-marked MRI systems (PDF, 1 MB, 30.04.2019)

BW510_00_004e_FO Clinical Trials with medical devices: Submission for approved trial (PDF, 1 MB, 30.04.2019)

BW510_00_005e_FO Clinical Trials with medical devices Application for authorisation (PDF, 1 MB, 30.04.2019)

BW510_00_006e_FO Clinical trials of medical devices: Serious adverse events and deficiencies in Switzerland (PDF, 1 MB, 30.04.2019)

20.03.2019

Checkliste für die Inspektion der Meldung schwerwiegender Vorkommnisse (Materiovigilance) sowie der Instandhaltung von Medizinprodukten (PDF, 1 MB, 20.03.2019)Document available in German, French or Italian

13.02.2019

BW540_00_002e_FO Ordering of export certificates and manufacturing certificates for medical devices (PDF, 1 MB, 02.04.2019)

BW540_00_003e_MB Export certificates and manufacturing certificates for medical devices (PDF, 376 kB, 13.02.2019)

Permanent link of this page
www.swissmedic.ch/md-en

Contact

Swissmedic
Division medical devices
Hallerstrasse 7
3012 Berne
Switzerland

General questions about medical devices

Troubleshooting for PDF forms

Last modification 30.04.2019

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