Alert - Medical Device Authority (MDA)

List of articles in category Alerts
Tajuk	Dikunjungi
December 2021 : Corrective Action Notification FCO-02961-D : Single FOV Static PET reconstruction bug	Dikunjungi: 2343
December 2021 : Notification on Initial Report for CR-2021-IGT-PUN-011 (FCO71800101) - Zenition 70 Wireless Footswitch Safety Notification : Wireless footswitch connection issues causing interruption of live Fluoroscopy imaging or exposure	Dikunjungi: 2431
December 2021 : FSN : QIAcube Connect MDx Instrument REF 9003070 - issue with the text contained within several protocols which run on the QIAcube® Connect MDx instrument.	Dikunjungi: 4783
December 2021 : Field Safety Notice NC 3946 DEFIGARD Touch 7 (Initial Report) : Possible that a defibrillation shock cannot be delivered.	Dikunjungi: 2276
December 2021 : Field Safety Notice ICSMA-21-343-01 - SSO Password Vulnerability for Cardiology Products : Unauthorized access to application functions and patient data	Dikunjungi: 1983
December 2021 : Initial Reporting FA 21072 : Field Safety Notification on AU/DxC AU Magnesium - IFU update due to lipemic interference for the Magnesium serum application failed to meet the performance specification.	Dikunjungi: 2033
November 2021 : Customer Safety Information (CSI) for Field Safety Corrective Action FCA AX077/21/S \| FSN AX078/21/S, AX081/21/S : ComboBox does no longer login automatically after several reboots. Calculation of Cardiac Output (Thermodilution method) on	Dikunjungi: 2424
November 2021 : FSN-2021-013 DR0155M Thermo Scientific™ Campylobacter Test Kit: Auto-agglutinating in all the test latexes with + to ++ reactions.	Dikunjungi: 5389
November 2021 : FCA Notification - iDesign Advanced Wavescan Studio System : Patch installation due to potential cybersecurity vulnerability concerning the Windows Print Spooler Service.	Dikunjungi: 2136
November 2021 : FCA Notification - CATALYS™ Precision Laser System : Patch installation due to potential cybersecurity vulnerability concerning the Windows Print Spooler Service.	Dikunjungi: 4681

Halaman 3 dari 14

	Pihak Berkuasa Peranti Perubatan Malaysia, Kementerian Kesihatan Malaysia, Aras 6, Prima 9, Prima Avenue II, Block 3547, Persiaran APEC, 63000 Cyberjaya, Selangor, MALAYSIA
	+603 - 8230 0300
	+603 - 8230 0200