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Recall Observatory FDA recall evidence

Device product

C3 Wave App, v. 2.0.5

Z-0222-2020

October 01, 2018

Class II

Product summary

Firm
Medical Components, Inc dba MedComp
Event
Event 81439
Status
Terminated
Classification
Class II
Quantity
24
Official record key
device-enforcement:Z-0222-2020

Official wording

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.

Code information: v. 2.0.5; all units

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.