Recall Z-0222-2020— Medical Components, Inc dba MedComp
Class II · Terminated
Class II FDA medical device recall by Medical Components, Inc dba MedComp, initiated 2018-10-01, terminated 2020-10-01. It names one FDA 510(k) clearance: K170934. 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..
- Recalling firm
- Medical Components, Inc dba MedComp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-10-01
- Terminated
- 2020-10-01
- Firm location
- Harleysville, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.