№ files_lp_3_process_7_110068
Compilation of regulatory safety communications listing urgent field safety notices issued in Germany for specific medical devices and diagnostic products identified as posing a serious risk during the stated reporting period.
Country: Germany
Reporting authority: BfArM (Federal Institute for Drugs and Medical Devices)
Reporting period: 01.04.2024–30.06.2024
Type of document: Compilation of Urgent Field Safety Notices
Subject: Medical devices posing a serious risk
Product categories: In-vitro diagnostics; Medical electronics; Non-active implants; Surgical and anaesthesia equipment; Radiological equipment; Ultrasonic diagnostic equipment; Infusion and transfusion devices; Ophthalmological technology; General medical treatment equipment
Manufacturers involved: tecfor care GmbH; Stryker Neurovascular; Siemens Healthcare GmbH; Siemens Healthcare Diagnostics Products Ltd.; LIMACORPORATE S.P.A.; Baxter Medical Systems GmbH + Co. KG; Olympus Medical Systems Corp.; Philips Medizin Systeme Böblingen GmbH; Schiller AG; Thermo Fisher Scientific Oy; Abaxis Inc.; QIAGEN GmbH; Radiometer Medical ApS; Terumo BCT, Inc.; and others
Reference numbers: 11838/24; 11839/24; 18431/24; 20711/24; 20505/24; 20347/24; 20596/24; 18645/24; 20027/24; 20416/24; 35137/23; 16702/24; 18927/24; 18178/24; 17789/24; 19867/24; 20295/24; 19882/24; 18372/24; 18755/24; 18518/24; 14867/24; 17753/24; 17474/24; 16184/24; 05281/24; 18158/24; 18592/24; 17213/24; 16636/24; 19272/24; 17856/24; 16200/24; 14035/24; 34916/23
Source links: https://www.bfarm.de/EN/Medical-devices/Tasks/Risk-assessment-and-research/Field-corrective-actions/_node.html
; https: //www.bfarm.de/SharedDocs/Kundeninfos/DE/10/2022/29316-21_kundeninfo_de.pdf?__blob=publicationFile
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