Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1987-2015Class II

Philips GoSafe Communicator 7000L Personal emergency response system

Lifeline Systems, Inc. / initiated 2015-04-22 / Terminated / root cause: software

Lifeline Systems, Incorporated began a recall of Philips GoSafe Communicator 7000L Personal emergency response system on . FDA classified it as Class II and gives the reason as "Home communicator Model 7000L may not sense the phone line under certain unusual landline phone conditions". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-1987-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Lifeline Systems, Inc.
Product
Philips GoSafe Communicator 7000L Personal emergency response system.
Product code
ILQ System, Communication, Powered
Reason for recall
Home communicator Model 7000L may not sense the phone line under certain unusual landline phone conditions.
Root cause tag
software
FDA root cause
Software design
Action
Philips Lifeline notified all consignees of the recall via phone starting on April 22, 2015. The call informs consignees of the issue and actions to be taken. For questions, consignees can contact customer service at 1-800-451-0525 ext. 1608. Consignees were also sent a letter to all consignees instructing them that Lifeline would send out a qualified Installiation Representative for an equipment exchange.
Quantity in commerce
3189 devices total, 38 are subject to recall
Distribution
Nationwide Distribution including AK AZ CA CT FL IA IL KY MA MD MT NC NE NH NY OH OR SC VA WA and WI.
Product codes and lots
Serial Numbers: 9030003931 9030001761 9030002025 9030002242 9030001588 9030000853 9030001696 9030003178 9030003086 9030000589 9030001526 9030003837 9030000681 9030003507 9030000600 9030001060 9030001517 9030004154 9030002875

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1987-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1987-2015Class IITerminatedVoluntary: Firm initiated