Recall – Network manager software error leads to nurse call system outage

Company: Stanley Security Solutions Inc
Date of Enforcement Report: 7/31/2019
Class II

PRODUCT

STANLEY Healthcare Arial 54315 Network Manager

Recall Number: Z-1996-2019

REASON

STANLEY Healthcare has received reports of outages on the Arial nurse call system. These outages have been traced back to the Arial¿ 54315 Serial-to-IP Network Gateway.

RECALLING FIRM/MANUFACTURER

Stanley Security Solutions Inc on 6/14/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
137 units

DISTRIBUTION

US Nationwide and Canada

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.