Z-0222-2020Class II

C3 Wave App, v. 2.0.5

Name: Z-0222-2020 C3 Wave App, v. 2.0.5
Creator: Medical Components, Inc dba MedComp
Published: 2018-10-01
License: https://open.fda.gov/license/

Medical Components, Inc. / initiated 2018-10-01 / Terminated / root cause: software

FDA source

Medical Components, Inc dba MedComp began a recall of C3 Wave App, v. 2.0.5 on 2018-10-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0222-2020
Classification: Class II
Status: Terminated
Initiated: 2018-10-01
Posted: 2019-10-25
Terminated: 2020-10-01
Recalling firm: Medical Components, Inc.
Product: C3 Wave App, v. 2.0.5
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
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.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: On October 1, 2018, the firm notified its customers via Product Advisory Notification letter. The letter communicated to customers that the most recent iOS version (12) was incompatible with the C3 Wave app v. 2.0.5. The firm released v.2.0.6 of the app on 10/3/2018, which was made available in the app store. Customers were asked to update both the iOS and the C3 app at the same time to avoid any issues within the app. Customers were provided with step-by-step directions on how to do this. If you have any questions, please contact [email protected].
Quantity in commerce: 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.
Product codes and lots: v. 2.0.5; all units

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0222-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0222-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-25

Product code LJS

K170934Class IIC3 Wave SystemMedical Components, Inc (Dba Medcomp_ / cleared 2017-12-06

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)