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Open, Classified

ZVU Functional GI Software, REF: ZVU-3

FDA Recall Z-2521-2023 · Posted 2023-09-07

Recalling FirmDiversatek Healthcare
Recall StatusOpen, Classified
Product CodeFFX
Date Initiated2023-07-25
Product Quantity20

Reason for Recall

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

Firm Action

Starting on 7/25/23 recall notices were mailed and emailed to customers asking them to do the following: 1) Discard affected product. 2) Contact customer service 1-800-558-6408 for replacement. 3) Complete and return the acknowledgement and receipt form.

Root Cause

Labeling Change Control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K012232INSIGHT, MODEL S980000Sandhill Scientific, Inc. · 2002-06-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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