C3 Wave App, v. 2.0.5
FDA Recall Z-0222-2020 · Posted None
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Recalling FirmMedical Components, Inc dba MedComp
Recall StatusTerminated
Product CodeLJS
Date Initiated2018-10-01
Date Terminated2020-10-01
Product Quantity24
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.
Firm Action
On October 1, 2018, the firm notified its customers via Product Advisory Notification letter. The letter communicated to customers that the most recent iOS version (12) was incompatible with the C3 Wave app v. 2.0.5.
The firm released v.2.0.6 of the app on 10/3/2018, which was made available in the app store. Customers were asked to update both the iOS and the C3 app at the same time to avoid any issues within the app. Customers were provided with step-by-step directions on how to do this.
If you have any questions, please contact [email protected].
Root Cause
Software Manufacturing/Software Deployment
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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