FDAOctober 1, 2018device

C3 Wave App, v. 2.0.5

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

medical components inc dba medcompmedicalmedical components

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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