Recall Z-1682-2020— CHANGE HEALTHCARE CANADA COMPANY

Name: FDA recall Z-1682-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-10

Class II · Ongoing

Class II FDA medical device recall by CHANGE HEALTHCARE CANADA COMPANY, initiated 2020-02-10. It names one FDA 510(k) clearance: K113515. Product: McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management. Reason: 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.

Recalling firm: CHANGE HEALTHCARE CANADA COMPANY
Classification: Class II
Status: Ongoing
Initiated: 2020-02-10
Firm location: Richmond, British Columbia, Canada

510(k) clearances named in this recall

1 on FDA's record

K113515 — HORIZON CARDIOLOGY ECG MANAGEMENTMckesson Israel , Ltd.·cleared 2012-03-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.