FDA Recall Terminated

Aruba Wireless Network Access Points, Model 65 utilized by the Acuity Central Monitoring System. Welch Allyn Protocol, Inc. Intended for use by clinicians for the central monitoring of neonatal, pediatric and adult patients in health care facilities. The system connects to a network of patient monitors to record and analyze physiological data being acquired by the monitors.

Recall: Z-2918-2011 · Initiated May 16, 2011

Recall

Recall Number
Z-2918-2011
Event Number
58978
Firm
Welch Allyn Protocol, Inc
FEI Number
3023750
Product Code
DSI
Status
Terminated
Root Cause
Software design
Initiated
May 16, 2011
Posted
August 3, 2011
Terminated
August 12, 2011
Address
8500 Sw Creekside Pl, Beaverton, OR, 97008

Description

Aruba Wireless Network Access Points, Model 65 utilized by the Acuity Central Monitoring System. Welch Allyn Protocol, Inc. Intended for use by clinicians for the central monitoring of neonatal, pediatric and adult patients in health care facilities. The system connects to a network of patient monitors to record and analyze physiological data being acquired by the monitors.

Reason

Aruba Wireless Network Access Points, Model Number 65, experienced a higher than expected incidence of dropouts due to external RF interference.

Action

Welch Allyn Protocol, Inc. sent a letter dated May 16, 2011 to affected customer. The letter stated there were concerns over drop-outs in the system recommended the system at this hospital to revert back to the Symbol wireless infrastructure. For questions call Welch Allyn at 315-685-4100.

Distribution

Worldwide distribution: (USA) Nationwide distribution including the state of California; and the countries of Singapore; Philippines, France, Italy, Malaysia, Poland, UK, England, UAE, Germany, Spain, Ireland, Portugal, New Zealand, Hong Kong, Thailand, Australia, Canada, and the Netherlands.

Quantity

12 units were affected