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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 ...
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 ...
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 ...
FUJIFILM Irvine Scientific, Inc., FSN-RWN# 21001, Vitrification Freeze Kit
Dit herziene veiligheidsbulletin dient om aanvullende informatie te verstrekken over de Vitrification Freeze Kit:...
Factsheet: onderzoek chirurgische mondmaskers
De Inspectie Gezondheidszorg en Jeugd houdt toezicht op de wet- en regelgeving die geldt voor chirurgische mondmaskers. In deze ...
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 ...
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 ...
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 ...
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, ...
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 ...