Medical Components, Inc dba MedComp: Medical Device Recall in 2019 - (Recall #: Z-0222-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

C3 Wave App, v. 2.0.5

Product Classification:

Class II

Date Initiated: October 1, 2018

Date Posted: November 6, 2019

Recall Number: Z-0222-2020

Event ID: 81439

Reason for Recall:

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.

Status: Terminated

Product Quantity: 24

Code Information:

v. 2.0.5; all units

Distribution Pattern:

Distributed to accounts in AZ, CA, CO, FL, IL, LA, MA, ME, NC, OH, TN, VA, and WV. Foreign distribution to Canada, Croatia, Czech Republic, Great Britain, Greece, Italy, Netherlands, Slovenia, and Sweden.

Voluntary or Mandated:

Voluntary: Firm initiated