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

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

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