Sep

2023

FDA Recall: Software Incorrectly Labeled

Allison Pate

News

fda, recall

Company: Diversatek Healthcare
Date of Enforcement Report: 09/07/2023
Class III

PRODUCT

ZVU Functional GI Software, REF: ZVU-3

Recall Number:

Z-2521-2023

REASON:

GI software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.

RECALLING FIRM/MANUFACTURER:

Diversatek Healthcare

VOLUME OF PRODUCT IN COMMERCE:

DISTRIBUTION:

Worldwide – US Nationwide distribution in the states of NJ, MN, TN, WA, KY, OR, FL, GA, NY, TX, CO, KS and the countries of Japan, Saudi Arabia.

About the author

Allison Pate

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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FDA Recall: Software Incorrectly Labeled

Allison Pate

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