Recall Z-2263-2012 ยท NSX
Cisco Systems Inc
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
| Date | Aug 24, 2012 (initiated Jul 23, 2012) |
| Status | Terminated |
| 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 |
| Root cause | 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 | 1 unit |
| Distribution | Nationwide Distribution including the state of TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.