Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0222-2020 — C3 Wave App, v. 2.0.5

U.S. FDA — Device Enforcement · United States · 2018-10-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0222-2020
Date of alert
2018-10-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medical Components, Inc dba MedComp
Product category
device
Product type
Devices
Reported risk: When the iPad is updated with Apple iOS software version 12, the C3 application malfunctions. Upon launching a new procedure, the ECG waves do not appear on the screen, in surface or internal mode. If the C3 application is not operating properly, the PICC procedure must be completed without using alternate methods to confirm PICC tip placement.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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