Alert

Articles
Tajuk	Dikunjungi
December 2021 : FCA Notification 2021-003M _Olympus Evis Exera II Duodenovideoscope TJF-Q180V : Supplemental material for inspection.	5957
December 2021 : Field Correction Action Report - DELFIA® Xpress_R2021004 : Potential for decreased analyte measurement with DELFIA® Xpress hAFP, Free hCGß, PAPP-A, and hCG kits	8866
December 2021 : [TC2021-192] [Follow Up: Urgent Product Correction] [Availability of Application Software Version 5.13.4 Modification (MOD) 58 & 0.5M NaOH Usage Guidelines for ORTHO VISIONR and ORTHO VISIONR Max Analyzer]	6059
December 2021 : FSN 0321 MCC/21/005/IU : Sevoflurane vaporizers for Flow Family Anesthesia systems - presence of a yellow substance in the vaporizer.	10454
December 2021 : Field Safety Notification FA-21073 on AU/DxC AU Uric Acid : Failed to meet the conjugated bilirubin interference specification for the serum application as defined in IFU	10561
December 2021 : Corrective Action Notification FCO-02961-D : Single FOV Static PET reconstruction bug	6074
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	5788
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.	13754
December 2021 : Field Safety Notice NC 3946 DEFIGARD Touch 7 (Initial Report) : Possible that a defibrillation shock cannot be delivered.	6512
December 2021 : Field Safety Notice ICSMA-21-343-01 - SSO Password Vulnerability for Cardiology Products : Unauthorized access to application functions and patient data	6677

Tajuk

Dikunjungi

December 2021 : FCA Notification 2021-003M _Olympus Evis Exera II Duodenovideoscope TJF-Q180V : Supplemental material for inspection.

5957

December 2021 : Field Correction Action Report - DELFIA® Xpress_R2021004 : Potential for decreased analyte measurement with DELFIA® Xpress hAFP, Free hCGß, PAPP-A, and hCG kits

8866

December 2021 : [TC2021-192] [Follow Up: Urgent Product Correction] [Availability of Application Software Version 5.13.4 Modification (MOD) 58 & 0.5M NaOH Usage Guidelines for ORTHO VISIONR and ORTHO VISIONR Max Analyzer]

6059

December 2021 : FSN 0321 MCC/21/005/IU : Sevoflurane vaporizers for Flow Family Anesthesia systems - presence of a yellow substance in the vaporizer.

10454

December 2021 : Field Safety Notification FA-21073 on AU/DxC AU Uric Acid : Failed to meet the conjugated bilirubin interference specification for the serum application as defined in IFU

10561

December 2021 : Corrective Action Notification FCO-02961-D : Single FOV Static PET reconstruction bug

6074

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

5788

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.

13754

December 2021 : Field Safety Notice NC 3946 DEFIGARD Touch 7 (Initial Report) : Possible that a defibrillation shock cannot be delivered.

6512

December 2021 : Field Safety Notice ICSMA-21-343-01 - SSO Password Vulnerability for Cardiology Products : Unauthorized access to application functions and patient data

6677

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