Company: Medical Components, Inc dba MedComp
Date of Enforcement Report: 11/6/2019
Class II
PRODUCT
C3 Wave App, v. 2.0.5
- Recall Number: Z-0222-2020
REASON
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.
RECALLING FIRM/MANUFACTURER
Medical Components, Inc dba MedComp on 10/1/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
24
DISTRIBUTION
Nationwide and International