Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.586 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Alere San Diego,FCA-00000283, Cholestech LDX Analyzer
This letter is to inform you that Alere San Diego has recently revised the Cholestech LDX™ Battery label warning to include the ...
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Illumina, Inc., NextSeq 550Dx, MiSeqDx, NovaSeq 6000Dx instruments, the Illumina DRAGEN Server for NextSeq 550Dx, the Illumina DRAGEN Server v4, VeriSeq Onsite Server v2.
While conducting routine cybersecurity analysis, Illumina’s Product Security Team identified an uncontrolled product security ...
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Channel Medsystems, Inc., 3012018285.04242024.C.00001, Cerene Cryotherapy Device
Error code 003 was not listed in certain rows of the Cerene Cryotherapy Device Instructions for Use “Troubleshooting” section ...
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Stryker Joint Replacement, RA2024-3589151, EXETER 2.5 I M PLUG
Stryker has discovered the potential that the size on the package label of the EXETER 2.5 I M PLUG may not match the device ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...