FDA recall Z-0222-2020

Product

C3 Wave App, v. 2.0.5

Reason for recall

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.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2018-10-01

Report date

2019-11-06

Termination date

2020-10-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Harleysville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0222-2020