CLASS II Device recall · Reported 6 Nov 2019 · FDA Enforcement Report

C3 Wave App, v recalled by Medical Components

Medical Components is recalling C3 Wave App, v, distributed in 13 states. The recall was initiated on 1 Oct 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesv. 2.0.5; all units

Quantity recalled24

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0222-2020
FDA event ID: 81439
Recalling firm: Medical Components, Harleysville, PA
Classification: Class II
Status: Terminated
Recall initiated: 1 Oct 2018
FDA classified: 25 Oct 2019
Reported: 6 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Medical Software

Timeline

1 Oct 2018	Recall initiated by company
25 Oct 2019	Classified by FDA	+389 days
6 Nov 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

C3 Wave App, v. 2.0.5

Where it was distributed

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.

Arizona California Colorado Florida Illinois Louisiana Massachusetts Maine North Carolina Ohio Tennessee Virginia West Virginia

Questions about this recall

Is C3 Wave App, v recalled?

Yes. Medical Components recalled C3 Wave App, v on 1 Oct 2018. The recall is Class II and its status is Terminated. Recall number Z-0222-2020.

Why was it recalled?

Which lots are affected?

v. 2.0.5; all units

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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