Recall Z-0222-2020 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Medical Components, Inc dba MedComp
C3 Wave App, v. 2.0.5
| Date | Oct 1, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software Manufacturing/Software Deployment |
| 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 Recalls@medcompnet.com. |
| Quantity | 24 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170934 | C3 Wave System Medical Components, Inc (Dba Medcomp_, Dec 6, 2017 |