Medical devices
The manufacturer Bioteck S.p.A. has published the following safety information due to the detected counterfeiting of its medical device "CHONDROGRID® - INJECTABLE COLLAGEN HYDROLYSATE - 1 BTL 4MG" on the Turkish market
Safety warnings
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Medical devices
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13/06/2024
The manufacturer Bioteck S.p.A. of the CE-marked medical device CHONDROGRID® informs that counterfeits of this product have been found in Turkey.
The manufacturer Bioteck S.p.A. has published the following safety information due to the detected counterfeiting of its medical device "CHONDROGRID® - INJECTABLE COLLAGEN HYDROLYSATE - 1 BTL 4MG" on the Turkish market
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Safety information on the medical device KLASSIKER forearm crutches, models 220 and 230
Safety warnings
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Medical devices
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05/02/2024
The Federal Office for Safety in Health Care (BASG) warns against breaking KLASSIKER forearm crutches, models 220 and 230. Only certain LOT numbers are affected.
Safety information on the medical device KLASSIKER forearm crutches, models 220 and 230
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The manufacturer Medtronic has published the following safety information due to stolen and subsequently illegally marketed non-compliant medical devices of the type "McGRATH MAC Video Laryngoscope".
Safety warnings
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Medical devices
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09/11/2023
Medtronic Notification of Stolen Defective Products – Potentially Defective McGRATH™ MAC Video Laryngoscopes
NOTE: McGRATH™ MAC video laryngoscopes purchased directly from Medtronic or via its authorized distributors are not affected by this safety notice.
The BASG strongly recommends that medical devices should only be purchased through trusted distribution channels.
The manufacturer Medtronic has published the following safety information due to stolen and subsequently illegally marketed non-compliant medical devices of the type "McGRATH MAC Video Laryngoscope".
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Safety Information for Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30 and BiPAP A30/A40 Series Medical Device Models and CPAP and Bi-Level PAP Devices
Safety warnings
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Medical devices
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29/06/2021
With this letter, the Federal Office for Safety in Health Care (BASG) draws attention to a possible risk from devices manufactured by Respironics, Inc. (Philips Respironics). The medical devices concerned are ventilators.
Safety Information for Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30 and BiPAP A30/A40 Series Medical Device Models and CPAP and Bi-Level PAP Devices
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Safety alert issued by the Federal Office for Safety in Health Care regarding Dermapen 3 Microneedles.
Safety warnings
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Medical devices
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28/09/2020
The safety of these medical devices has not been proven. Based on the information currently available, the Federal Office therefore warns all potential users against further use of these medical devices.
Safety alert issued by the Federal Office for Safety in Health Care regarding Dermapen 3 Microneedles.
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Possible risk from contraceptive coils from the manufacturer Eurogine S.L.
Safety warnings
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Medical devices
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28/09/2020
With this letter, the Federal Office for Safety in Health Care (BASG) draws attention to a possible risk from intrauterine devices (IUDs) for contraception manufactured by Eurogine S.L..
Possible risk from contraceptive coils from the manufacturer Eurogine S.L.
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Safety warning for the medical device "Raindrop Near Vision Inlay".
Safety warnings
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Medical devices
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22/01/2019
The product "Raindrop Near Vision Inlay" is a medical device for the treatment of presbyopia.
(presbyopia). It is implanted into the cornea of an eye and causes a change in the shape of the cornea.
Cornea, which is intended to improve sharp near vision.
Safety warning for the medical device "Raindrop Near Vision Inlay".
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Safety warning for medical devices of the manufacturer LOGIMED Medizinische Spezialprodukte Gesellschaft m.b.H.
Safety warnings
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Medical devices
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11/09/2018
The Federal Office for Safety in Health Care (BASG) has been informed that "LOGIMED Medizinische Spezialprodukte Gesellschaft m.b.H., Gösserstraße 11, 8700 Leoben" (Logimed), which was liquidated in 2011, has no legal successor who continues to fulfil the manufacturer obligations arising from the Medical Devices Act (MPG), Federal Law Gazette No. 657/1996, as amended. These obligations include Post Market Surveilance System (PMS), which includes the investigation of incidents and, where appropriate, the initiation of safety corrective actions in the field.
Safety warning for medical devices of the manufacturer LOGIMED Medizinische Spezialprodukte Gesellschaft m.b.H.
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Safety warning concerning Aquilon2, Aquilon, Aquilon+ and Aquilon Pro series nebuliser
Safety warnings
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Medical devices
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18/07/2018
The BASG has been approved by the competent authority in Great Britain (Medicines & Healthcare products
Regulatory Agency - MHRA) informs that the products listed are unlawfully available on the market.
were brought. The manufacturer has not provided sufficient evidence that the products comply with the
comply with legal requirements.
Safety warning concerning Aquilon2, Aquilon, Aquilon+ and Aquilon Pro series nebuliser
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