FDA-Device2019-11-06Class II
C3 Wave App, v. 2.0.5
Medical Components, Inc dba MedComp
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.
Sold states
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.
Affected count
24
Manufactured in
1499 Delp Dr, Harleysville, PA, United States
Products
C3 Wave App, v. 2.0.5
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0222-2020Don't want to check this manually?
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