Atlas FDA

Philips GoSafe Communicator 7000L Personal emergency response system.

FDA device recall Z-1987-2015 · posted 2015-07-06 · Terminated

Recall details

Recalling firm
Lifeline Systems, Incorporated
Reason for recall
Home communicator Model 7000L may not sense the phone line under certain unusual landline phone conditions.
Action taken
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.
Root cause
Software design
Status
Terminated
Product code
ILQ
Quantity affected
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.
Date initiated
2015-04-22
Date posted
2015-07-06
Date terminated
2016-08-24
Location
Framingham, MA

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Related 510(k) clearances

RecordFirmDate
LIFELINE(R) PERSONAL RESPONSE SYSTEM (K914103)Lifeline Systems, Inc.1991-09-27