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.
FDA Recall Z-2918-2011 · Posted 2011-08-03
Advertisement
Recalling FirmWelch Allyn Protocol, Inc
Recall StatusTerminated
Product CodeDSI
Date Initiated2011-05-16
Date Terminated2011-08-12
Product Quantity12 units were affected
Reason for Recall
Aruba Wireless Network Access Points, Model Number 65, experienced a higher than expected incidence of dropouts due to external RF interference.
Firm 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.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement