Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management see related information
Date Initiated by Firm February 10, 2020
Create Date April 08, 2020
Recall Status1 Open3, Classified
Recall Number Z-1682-2020
Recall Event ID 85068
510(K)Number K113515  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
Code Information McKesson Cardiology Software Versions: 13.2.1 HF1, 13.2.1 HF2, 14.0, 14.0 HF1, 14.0 HF2;   Change Healthcare Software Versions: 14.1.1, 14.2 
Recalling Firm/
Manufacturer		 CHANGE HEALTHCARE CANADA COMPANY
10711 Cambie Rd Suite 130
Richmond Canada British Columbia
Manufacturer Reason
for Recall		 Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format
FDA Determined
Cause 2		 Device Design
Action Change Healthcare Canada Company notified customers on about 02/10/2020 via "Urgent Field Safety Notice" letter. Customers were informed of an issue whereby users who are estimating heart rate by counting grid squares, may assume that the Sequential ECG format is presented on a scale of 25 mm/sec and thereby may inaccurately estimate the heart rate value. Instructions included that the Simultaneous ECG format can be used rather than the Sequential ECG format, until the software is updated and the Sequential ECG format option can be used while maintaining awareness to the scale bar on the screen. Customers were also instructed to contact their users and train them on how to verify the ECG format mode they are working on and how they can change it. The notice needs to be distributed to all those within their organization who need to be aware and to please alert other parties affiliated with your organization that are affected by this field safety notice. Additionally, customers were informed that Change Healthcare is developing a software update that will enable presentation of the Sequential ECG format view using the 25 mm/sec scale and were requested to contact Change Healthcare Customer Support to: 1) Acknowledge they have read and understood this Urgent Field Safety Notice and 2) Arrange installation of software update/upgrade. Change Healthcare Customer Support contacts: - US / Canada: 1 866-777-0202 - UK / Ireland: +44 (0) 208 9527399
Quantity in Commerce 51 units
Distribution Distribution US nationwide, Canada and the United Kingdom
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DQK and Original Applicant = MCKESSON ISRAEL LTD.
-
-