Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

C3 Wave App Recalled by Medical Components, Inc dba MedComp Due to When the iPad is updated with Apple iOS...

Date: October 1, 2018
Company: Medical Components, Inc dba MedComp
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medical Components, Inc dba MedComp directly.

Affected Products

C3 Wave App, v. 2.0.5

Quantity: 24

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 13 states: AZ, CA, CO, FL, IL, LA, ME, MA, NC, OH, TN, VA, WV

Affected (13 states)Not affected

About Medical Components, Inc dba MedComp

Medical Components, Inc dba MedComp has 38 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report