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Use caution Medical device recall · FDA · Published October 1, 2018

MedComp C3 Wave App v. 2. 0.5: ECG waves not showing after iOS 12 update

MedComp recalls C3 Wave App v. 2.0.5 due to ECG waves not appearing after iOS 12 update, risking incorrect PICC placement.

🇺🇸 FDA recall #Z-0222-2020Medical deviceMedComp ›
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Contact the company

Recalling firmMedical Components, Inc dba MedComp1499 Delp Dr · Harleysville, PA 19438-2936
✎ GovInfoNow plain-language explainer

MedComp recalls its C3 Wave App version 2.0.5 because it stops showing ECG waves when updated to iOS 12. This could lead to incorrect PICC placement during procedures if the app isn't working properly. Read more at govinfonow.com/recall/69709-medcomp-c3-wave-app-v-2-0-5-ecg-waves.

Source Summary by GovInfoNow · govinfonow.com/recall/69709-medcomp-c3-wave-app-v-2-0-5-ecg-waves · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0222-2020

Cite this page

“MedComp C3 Wave App v. 2. 0.5: ECG waves not showing after iOS 12 update.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69709-medcomp-c3-wave-app-v-2-0-5-ecg-waves. Based on FDA recall #Z-0222-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0222-2020%22&limit=1).

The FDA announced on 2018-10-01 that Medical Components, Inc dba MedComp is recalling the C3 Wave App, v. 2.0.5 because it malfunctions when the iPad is updated with Apple iOS software version 12. The app fails to display ECG waves upon launching a new procedure. GovInfoNow's records show this Class II recall has been terminated.

How to tell if you have it

  • Brand: MedComp
  • Product: C3 Wave App, v. 2.0.5
  • Units affected: all units

The hazard

According to the FDA, 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. The record states that if the application is not operating properly, the PICC procedure must be completed without using alternate methods to confirm PICC tip placement.

Context

GovInfoNow's records show Medical Components, Inc dba MedComp has had 7 other recalls on record since 2017-11-22. Other recent recalls of similar products include MedComp Power Injectable CT Port Kits Recalled: Incorrect Port Size May Prolong Surgery (2021-01-13), MedComp 15.SF X 24CM Titan HD Catheter Recall: Incorrect Valve Size Risk (2020-07-27), and MedComp Hemodialysis Catheter Kits Recalled: Incorrect Introducer Included (2019-03-13).

How to tell if you have this one

Check for the C3 Wave App version 2.0.5 on your device. The recall applies to all units sold with iOS 12 updates.

  • Brand
    MedComp
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check App Version

    Verify your C3 Wave App version is 2.0.5 by checking the app store or device settings.

  2. Update to Correct Version

    Update to a newer version of the C3 Wave App if available to ensure ECG waves display properly.

Where it went and when

Where it was distributed

Distributed in 13 states, and outside the U.S.

Alaska: not listedAKMaine: yesMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: yesMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: yesOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: yesCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: yesWVVirginia: yesVAMaryland: not listedMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: yesLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: yesFL

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Colorado, Florida, Illinois, Louisiana, Maine, Massachusetts, North Carolina, Ohio, Tennessee, Virginia, West Virginia.

Recall timeline

FDA terminated this recall 2 years after the firm started it.

1. Firm started the recall: Oct 1, 201812. FDA classified it Class II: Oct 25, 201923. Published in FDA’s Enforcement Report: Nov 6, 201934. FDA terminated the recall: Oct 1, 2020420182020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0222-2020 (October 1, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0222-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA