Z-0222-2020 Class II Terminated
FDA device recall Z-0222-2020 was initiated by Medical Components, Inc dba MedComp on October 1, 2018 and is designated Class II. 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. … The recall status is terminated (terminated October 1, 2020). Affected quantity: 24.
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2019
- Initiation Date
- October 1, 2018
- Termination Date
- October 1, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24
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.
Distribution Pattern
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.
Code Information
v. 2.0.5; all units