C3 Wave App recall: Software Issue
C3 Wave App, v. 2.0.5
Why was C3 Wave App 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
v. 2.0.5; all units
- Product
- C3 Wave App, v. 2.0.5
- Recalling firm
- Medical Components, Inc dba MedComp
- Quantity
- 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.
- Recall date
- November 6, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)