Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.244 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
- Datum
- Relevantie
-
Cook Ireland Ltd, 2024FA0002, ECHO-19: EchoTip® Ultra Endoscopic Ultrasound Needle; ECHO-HD-19-A: EchoTip® Ultra HD Ultrasound Access Needle
Tijdens het routinematige endotoxineprogramma zijn niveaus van bacteriële endotoxine geconstateerd die buiten specificatie ...
-
Balt USA, HHE-027, Optima Coil System, Prestige Coil System
The purpose of this letter is to advise affected customers that Balt USA is voluntarily recalling some lots of the Optima and ...
-
Alcon Laboratories, Inc., ClearCut Dual Bevel 1.2mm Sideport, Safety Dual Bevel 1.2mm Sideport, Safety Dual Bevel 1.0mm Sideport en 20G MVR. V-Lance Ophthalmic knives
Het gebruik van extra penetratiekracht tijdens een oogheelkundige ingreep in het voorste segment kan intraoperatieve ...
-
Megadyne Medical Products, Inc., MEGA SOFT Pediatric Patient Return Electrode
Megadyne has received reports of patient burn injuries in procedures where the Mega Soft Patient Return Electrodes were used. A ...
-
Arrow International LLC (Subsidiary of Teleflex Incorporated), EIF-000561, FiberOptix Ultra 8 IAB, Ultra 8 IAB, UltraFlex IAB
Teleflex is initiating this voluntary FSCA for the above-mentioned products due to reports indicating an infrequent condition ...
-
Gyrus ACMI, Inc. (Olympus Surgical Technologies America), QIL FY25-EMEA-01-FY23-OSTA-14-InstaClear Sheath, INSTACLEAR SHEATH
Olympus is taking this corrective action after investigating a complaint for an InstaClear Sheath (Model # LCS4K30BTOL) in which ...
-
GE Healthcare Finland Oy, FMI 36161, Carescape multi-parameter patient monitors
GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, ...
-
B.Braun Melsungen AG, FSCA-2024-04-23, EASYPUMP® II LT
Tijdens onze Post Market Surveillance-activiteiten heeft de fabrikant in één geval een aanzienlijke overmatige infusie in de ...
-
Beckman Coulter, 24019, DxI 9000 Access Immunoassay Analyzer
Beckman Coulter heeft vastgesteld dat de DxI 9000 Access Immunoassay-analysator kalibratorwaarden accepteert die zijn gescand ...
-
Intersurgical Ltd, 446776, Various Mapleson F Anaesthetic Breathing Systems
Some devices contain a reservoir bag with a closed tail, when they should have a reservoir bag with open tail.