medical Class II Updated 2019-11-06

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

Recalled Product

C3 Wave App, v. 2.0.5

Hazard / Issue

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.

Issued by

FDA

Affected States: AZ, CA, CO, FL, IL, LA, MA, ME, NC, OH, TN, VA, WV
Lot/Code Info: v. 2.0.5; all units
View official government recall

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