Recall – ECG app malfunctions when used with certain iPad software version

Company: Medical Components, Inc dba MedComp
Date of Enforcement Report: 11/6/2019
Class II

PRODUCT

C3 Wave App, v. 2.0.5

  • Recall Number: Z-0222-2020

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.

RECALLING FIRM/MANUFACTURER

Medical Components, Inc dba MedComp on 10/1/2018. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

24

DISTRIBUTION

Nationwide and International

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
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