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Terminated

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.

FDA Recall Z-2263-2012 · Posted 2012-08-24

Recalling FirmCisco Systems Inc
Recall StatusTerminated
Product CodeNSX
Date Initiated2012-07-23
Date Terminated2012-08-24
Product Quantity1 unit

Reason for Recall

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

Firm Action

Cisco notified their one customer by phone on July 25, 2012, with a follow up email and instructed the customer to stop using the OnePlace vitals tab and to use the CHP only. On July 27th, 2012, the vendor of the OnePlace application, fixed the bug remotely. On July 31, 2012, Cisco's staff physician contacted the customer to confirm that the customer was aware of the fix. Validation of the correction was completed by Cisco, along with customer on August 9, 2012. Until validation was satisfactorily completed, the integrated system lie dormant at customer's site.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution including the state of TN.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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