The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2263-2012·Announced 2012-09-05

Cisco HealthPresence Software Recall for Vital Signs Display Errors

Cisco Systems is recalling HealthPresence software version 2.1 because subsequent vital signs readings may not update correctly in the OnePlace tab, potentially leading to incorrect interpretations.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device software defect that may lead to incorrect interpretation of vital signs, posing a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Cisco Systems, Inc. is recalling Cisco HealthPresence software, version 2.1 (Model/Catalog Number: CHP-ENTPRSYR2.I-K9). The product is intended for remote consultation of patients with a healthcare provider, providing high-definition video, audio, and transmission of third-party medical device data. The recall is due to a software anomaly where subsequent vital signs readings update in the Cisco HealthPresence Vitals tab and the OnePlace database but fail to update under the OnePlace tab. This discrepancy may result in incorrect values and interpretations of patient data.

The affected software is distributed nationwide, including the state of Tennessee. The specific serial/code number for the affected units is 2.1.0.87. Cisco HealthPresence is not intended for use in emergency situations or for active patient monitoring and alarming. Users should be aware that while initial vital signs readings display accurately, subsequent readings may not reflect current data in all views, which could impact clinical decision-making during remote consultations.

The recalled product

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…
Manufacturer
Cisco Systems Inc
Category
Medical Device — Software
Hazard
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial/Code Number: 2.1.0.87

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same hazard · software defect

See all →

Similar recalls