Home / Recalls / Medical Devices
Medical Components, Inc dba MedComp recalls C3 Wave App, v. 2.0.5
Recalled November 6, 2019 · FDA recall Z-0222-2020 · Medical Components, Inc
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. · FDA Class II
Units
24
Sold at
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.
Description
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.
Product
C3 Wave App, v. 2.0.5
Manufacturer(s)
Medical Components, Inc dba MedComp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →