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U.S. Department of Health and Human Services

Class 2 Device Recall Cisco

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  Class 2 Device Recall Cisco see related information
Date Initiated by Firm July 23, 2012
Date Posted August 24, 2012
Recall Status1 Terminated 3 on August 24, 2012
Recall Number Z-2263-2012
Recall Event ID 62770
Product Classification Software transmission and patient data storage medical - Product Code NSX
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.
Code Information Serial/Code Number: 2.1.0.87
Recalling Firm/
Manufacturer		 Cisco Systems Inc
170 W Tasman Dr
San Jose CA 95134
For Additional Information Contact Robyn Stanton
408-527-5003
Manufacturer 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
FDA Determined
Cause 2		 Software design
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.
Quantity in Commerce 1 unit
Distribution Nationwide Distribution including the state of TN.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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