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Recall Observatory FDA recall evidence

Device 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.

Z-2263-2012

July 23, 2012

Class II

Product summary

Firm
Cisco Systems Inc
Event
Event 62770
Status
Terminated
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-2263-2012

Official wording

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

Code information: Serial/Code Number: 2.1.0.87

Distribution pattern: Nationwide Distribution including the state of TN.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software anomaly may result in incorrect