# FDA recall Z-0222-2020

> **Medical Components, Inc dba MedComp** · Class II · device recall initiated 2018-10-01.

## 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

- **Recall number:** Z-0222-2020
- **Recalling firm:** Medical Components, Inc dba MedComp
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0222-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0222-2020. Source: US FDA. Licensed CC0.

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