January 3, 2024

Jan

FDA Recall: Software Errors May Prohibit Use of New Systems Resulting in being Inoperable

January 3, 2024Allison PateNews

Company: Covidien Date of Enforcement Report: 1/3/2023 Class II PRODUCT Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD Recall Number: Z-0631-2024 REASON: Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable. RECALLING FIRM/MANUFACTURER: Covidien VOLUME OF PRODUCT IN COMMERCE:...

Jan

FDA Recall: Risk of Unexpected HeartMate Pump Stop or Start

January 3, 2024Allison PateNews

Company: Abbott Date of Enforcement Report: 1/3/2024 Class I PRODUCT HeartMate Touch Communication System (version 1.0.32) Recall Number: Z-0842-2024 REASON: Abbott is recalling their HeartMate Touch System (version 1.0.32) for risk of unexpected pump stop or start. Issues may occur if the HeartMate Touch System is disconnected from a patient’s HeartMate Controller while a “pump...

FDA Recall: Software Errors May Prohibit Use of New Systems Resulting in being Inoperable

FDA Recall: Risk of Unexpected HeartMate Pump Stop or Start

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FDA Recall: Software Errors May Prohibit Use of New Systems Resulting in being Inoperable

FDA Recall: Risk of Unexpected HeartMate Pump Stop or Start

Upcoming Public Courses

Corporate Office