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.
This recall has been terminated (originally issued August 3, 2011).
- Company
- Welch Allyn Protocol, Inc
- Recall Initiated
- May 16, 2011
- Posted
- August 3, 2011
- Terminated
- August 12, 2011
- Recall Number
- Z-2918-2011
- Quantity
- 12 units were affected
- Firm Location
- Beaverton, OR
- Official Source
- View on FDA website ↗
Reason for Recall
Aruba Wireless Network Access Points, Model Number 65, experienced a higher than expected incidence of dropouts due to external RF interference.
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.
Lot / Code Info
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.
Root Cause
Software design
Action Taken
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.