Recall Z-2263-2012— Cisco Systems Inc

Class II FDA medical device recall by Cisco Systems Inc, initiated 2012-07-23, terminated 2012-08-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured and distributed by Cisco Systems, Inc. San Jose, CA Cisco HealthPresence, version 2 is intended for remote consultation of patients with a healthcare provider. Cisco HealthPresence enables remote collaboration between a physician and a patient by providing: high-definition video and advanced audio; transmission and display of third-party medical device data; integration with third party EMR: scheduling: and other software applications for remote consultations and exams. Cisco Health Presence is not intended for use in emergency situations. Cisco HealthPresence is not intended for use in active patient monitoring or alarming.. Reason: Software anomaly may result in incorrect values and interpretations. The initial vital signs reading will display accurately on the Cisco Health Presence Vitals tab and the OnePlace tab. However, subsequent vital signs readings will only update on the Cisco HealthPresence Vitals tab and within the OnePlace database, but will not update under the OnePlace tab, and thus, will not provide current vit.

Recalling firm

Cisco Systems Inc

Classification

Class II

Status

Terminated

Initiated

2012-07-23

Terminated

2012-08-24

Firm location

San Jose, CA, United States

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