Recall Z-2521-2023— Diversatek Healthcare

Name: FDA recall Z-2521-2023
Creator: U.S. Food and Drug Administration
Published: 2023-07-25

Class III · Ongoing

Class III FDA medical device recall by Diversatek Healthcare, initiated 2023-07-25. It names one FDA 510(k) clearance: K012232. Product: ZVU Functional GI Software, REF: ZVU-3. Reason: GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0..

Recalling firm: Diversatek Healthcare
Classification: Class III
Status: Ongoing
Initiated: 2023-07-25
Firm location: Highlands Ranch, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K012232 — INSIGHT, MODEL S980000Sandhill Scientific, Inc.·cleared 2002-06-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ZVU Functional GI Software, REF: ZVU-3

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.