| Class 2 Device Recall McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management |  |
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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DQK
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