V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological par

FDA device recall Z-2059-2014 · posted 2014-07-16 · Terminated

Recall details

Recalling firm

Mindray DS USA, Inc. dba Mindray North America

Reason for recall

ECG interpretation feature issues. False measurements reported when the algorithm cannot determine P wave or QRS axis. The Median Complex Report displays the representative beat 25% larger than actual signal input. When a patient date of birth is imported from an external source, the ECG interpretation algorithm uses the default age of 50, and interpretive statements may be incorrect.

Action taken

Mindray issued "Urgent: V-Series Monitoring System Corrective Action" notices dated May 19, 2014, to customers that received the affected product via certified mail with return receipt verification. The notification informs the customer of the issues with the affected product and how to identify the affected product. The notification recommends that customers discontinue use of the 12-lead ECG interpretation feature until a software correction is available (anticipate August 2014). A point of contact is provided to customers in case they have questions. For further questions please call 1-800-288-2121.

Root cause

Software design

Status

Terminated

Product code

MHX

Quantity affected

113 units (57 United States; 56 International)

Distribution

Worldwide Distribution - US including the states of Louisiana, New Jersey, Montana, South Carolina and Wyoming.

Date initiated

2014-05-19

Date posted

2014-07-16

Date terminated

2017-04-20

Location

Mahwah, NJ