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U.S. Department of Health and Human Services

Class 2 Device Recall Aruba Wireless Access Points, Model 65

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 Class 2 Device Recall Aruba Wireless Access Points, Model 65see related information
Date Initiated by FirmMay 16, 2011
Date PostedAugust 03, 2011
Recall Status1 Terminated 3 on August 12, 2011
Recall NumberZ-2918-2011
Recall Event ID 58978
510(K)NumberK052160 
Product Classification Cardiovascular (Arrythmia) Detector and Alarm System - Product Code DSI
ProductAruba 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.
Code Information Model Number 65.   System Serial # TA00646 with TA01973, TA00668, TA00668-HA, TA00823, TA00823-HA, TA01968, TA01969, TA01970, TA01971, TA01972, TA01974, TA01975, TA02439, TA02444, and TA02444-HA.  The HA represents High Acuity and is a back-up system connected to the unit with the same number, except for TA00646 which is back up for TA01973. This unit did not originally have a back up and the other unit was not being used so they were combined. The numbers stayed the same for each system for tracking purposes.
Recalling Firm/
Manufacturer		 Welch Allyn Protocol, Inc
8500 Sw Creekside Pl
Beaverton OR 97008
For Additional Information Contact
503-530-7935
Manufacturer Reason
for Recall		Aruba Wireless Network Access Points, Model Number 65, experienced a higher than expected incidence of dropouts due to external RF interference.
FDA Determined
Cause 2		Software design
ActionWelch 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.
Quantity in Commerce12 units were affected
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = DSI
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