C3 Wave App — Class II medical device recall Z-0222-2020
Terminated recall by Medical Components, Inc dba MedComp, reported 2019-11-06, distributed in AZ, CA, CO, FL, IL, LA, MA, ME…. When the iPad is updated with Apple iOS software version 12, the C3 application malfunctions. Upon launching a
| Recall number | Z-0222-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medical Components, Inc dba MedComp, Harleysville, PA, United States |
| Recall initiated | 2018-10-01 |
| Classified | 2019-10-25 |
| Reported by FDA | 2019-11-06 |
| Terminated | 2020-10-01 |
| Distributed | AZ, CA, CO, FL, IL, LA, MA, ME, NC, OH, TN, VA, WV |
| Countries outside the US | CA, CZ, GB, GR, HR, IT, NL, SE, SI |
| Quantity | 24 |
| Reason classes | device malfunction, software |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0222-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.