Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1499-2017Class II

Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless emergency...

Securitas Healthcare LLC / initiated 2016-06-22 / Terminated / root cause: software

Stanley Security Solutions Inc began a recall of Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless emergency call management system. It enables residents in... on . FDA classified it as Class II and gives the reason as "Devices were incorrectly programmed during manufacturing therefore depressing the pendant button may result in an alarm not sounding as intended". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-1499-2017
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Securitas Healthcare LLC
Product
Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless emergency call management system. It enables residents in assisted living, skilled nursing or independent living to call staff with the press of a button.
Product code
ILQ System, Communication, Powered
Reason for recall
Devices were incorrectly programmed during manufacturing therefore depressing the pendant button may result in an alarm not sounding as intended.
Root cause tag
software
FDA root cause
Software design (manufacturing process)
Action
Stanley Healthcare sent an Important Recall Notice dated June 22, 2016, to all affected customers. The notice instructed customers to discontinue use of the device and to contact the recalling firm to arrange for return of the device. The recalling firm also asked the customer to complete a response form indicating they read, understood and complied with the recall notice. Customers with questions were instructed to contact Arial Customer Service at 888-716-0077. For questions regarding this recall call 781-216-9035.
Quantity in commerce
500 individual pendants
Distribution
Nationwide Distribution to AR, AZ, CA, FL, GA, IA, ID, IN, KS, MD, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SD, UT, VA, and WI.
Product codes and lots
Serial numbers WP149149 through WP149398 and WP149649 through WP149898.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1499-2017
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1499-2017Class IITerminatedVoluntary: Firm initiated