Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured...
Cisco Systems Inc began a recall of 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... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as software.
Recall record
- Recall number
- Z-2263-2012
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Cisco Systems Inc
- 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.
- Product code
- NSX
- 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
- Root cause tag
- software
- FDA 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 in commerce
- 1 unit
- Distribution
- Nationwide Distribution including the state of TN.
- Product codes and lots
- Serial/Code Number: 2.1.0.87
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2263-2012 | Class II | Terminated | Voluntary: Firm initiated |
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