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Siemens Healthcare Diagnostics, ASW 22-01, Atellica CH 930 Analyzer

Siemens Healthcare Diagnostics has identified issues with the Atellica Solution products listed in Table 1, which are installed ...

Waarschuwing | 07-01-2022

MatOrtho Limited, FSN-IE-2021-11-22-123, PIPR™

This FSN is to inform you that the indications and contraindications in the current instructions for use for these devices have ...

Waarschuwing | 07-01-2022

Bauerfeind AG, FSN-DE-MF-000007543, MOS-Genu; entspricht

The aluminum frame of the MOS-Genu knee orthosis (short and long versions) does not have the required material rigidity. That ...

Waarschuwing | 07-01-2022

FUJIFILM Irvine Scientific, Inc., FSN-RWN# 21001, Vitrification Freeze Kit

Dit herziene veiligheidsbulletin dient om aanvullende informatie te verstrekken over de Vitrification Freeze Kit:...  

Waarschuwing | 07-01-2022

Factsheet: onderzoek chirurgische mondmaskers

De Inspectie Gezondheidszorg en Jeugd houdt toezicht op de wet- en regelgeving die geldt voor chirurgische mondmaskers. In deze ...

Publicatie | 07-01-2022 | Inspectie Gezondheidszorg en Jeugd

Helena Biosciences Europe NC436 - V8 Electrophoresis analyser

Further to customer feedback regarding the V8 Nexus REF: 800008, 800018, and 800020, it has come to our attention that a ...

Waarschuwing | 06-01-2022

Abbott FA-AM-DEC2021-263 - Alinity m system

A software issue has been identified with the Alinity m System Software (Version 1.5.0 and greater) associated with the ability ...

Waarschuwing | 06-01-2022

Abbott FA-AM-DEC2021-264 - Alinity m system

Abbott Molecular Inc. has received two customer reports of Alinity m Resp-4-Plex false positive results and two customer reports ...

Waarschuwing | 06-01-2022

B Medical Systems FSCA_2021001 - Premium Line devices with FW5.8

The customer reported that the temperature displayed by the unit was 3.9°C, while the actual air temperature inside the unit, ...

Waarschuwing | 06-01-2022

Seemann Technologies 012021 - Sterile disposable bipolar forceps cable

The sterile disposable bipolar forceps cables are listed on the EC Directive certificate of the Notified Body not as a Class I ...

Waarschuwing | 06-01-2022