FDA Medical Device Recalls (openFDA)
Welch Allyn Protocol, Inc: 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 number
- Z-2918-2011
- Recalling firm
- Welch Allyn Protocol, Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2011-05-16
- Posted
- 2011-08-03
- Terminated
- 2011-08-12
- Reason
- Aruba Wireless Network Access Points, Model Number 65, experienced a higher than expected incidence of dropouts due to external RF interference.
- Root cause
- Software design
- 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.
- Quantity
- 12 units were affected
- 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, serial or model codes
- 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.
- 510(k) numbers
- ["K052160"]
- PMA numbers
- not on file
- Product code
- DSI
- Firm FEI
- 3023750
- Firm city
- Beaverton
- Firm state
- OR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28