03
Jan
2024

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

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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:

47,901 units

DISTRIBUTION:

Worldwide distribution – US: Nationwide and surrounding territories.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

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Lead Instructor: Mike Russell

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See our post titled: 1st Quarter 2025 Agile Compliant Courses Scheduled

 

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2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

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