Recall Z-2918-2011 ยท DSI Detector And Alarm, Arrhythmia
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.
| Date | Aug 3, 2011 (initiated May 16, 2011) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052160 | ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.) Welch Allyn, Inc., Dec 16, 2005 |