Device Recall VSeries 의 리콜

Recall

68582

Class 2

Z-2059-2014

2014-05-19

2014-07-16

Terminated

United States

2017-04-20

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128264

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.

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.