C3 Wave App, v. 2.0.5
Reported: November 6, 2019 Initiated: October 1, 2018 #Z-0222-2020
Product Description
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.
Details
- Recalling Firm
- Medical Components, Inc dba MedComp
- Units Affected
- 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.
- Location
- Harleysville, PA
Frequently Asked Questions
What product was recalled? ▼
C3 Wave App, v. 2.0.5. Recalled by Medical Components, Inc dba MedComp. Units affected: 24.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 6, 2019. Severity: Moderate. Recall number: Z-0222-2020.
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