Medical Components, Inc dba MedComp recalls C3 Wave App, v. 2.0.5

Recall date

October 1, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0222-2020

FDA classification

Class II

Brand / firm

Medical Components, Inc dba MedComp

Sold / distributed

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.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

C3 Wave App, v. 2.0.5