FDA Device recall Z-0222-2020
C3 Wave App, v. 2.0.5
- FDA Device
- Class II
- terminated
- Published 2019-11-06
On 2019-11-06 the FDA classified a Class II recall of C3 Wave App, v. 2.0.5 by Medical Components, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0222-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-01 |
| Published | 2019-11-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medical Components |
| Distribution | AZ, CA, CO, FL, IL, LA, MA, ME, NC, OH, TN, VA, WV |
Product
C3 Wave App, v. 2.0.5
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.
Identifiers
| code_info | v. 2.0.5; all units |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0222-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.