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U.S. Department of Health and Human Services

Class 2 Device Recall Philips GoSafe Communicator 7000L

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 Class 2 Device Recall Philips GoSafe Communicator 7000Lsee related information
Date Initiated by FirmApril 22, 2015
Date PostedJuly 06, 2015
Recall Status1 Terminated 3 on August 24, 2016
Recall NumberZ-1987-2015
Recall Event ID 71208
510(K)NumberK914103 
Product Classification System, communication, powered - Product Code ILQ
ProductPhilips GoSafe Communicator 7000L Personal emergency response system.
Code Information Serial Numbers: 9030003931 9030001761 9030002025 9030002242 9030001588 9030000853 9030001696 9030003178 9030003086 9030000589 9030001526 9030003837 9030000681 9030003507 9030000600 9030001060 9030001517 9030004154 9030002875 
FEI Number 1000086682
Recalling Firm/
Manufacturer		 Lifeline Systems, Incorporated
111 Lawrence St
Framingham MA 01702-8156
For Additional Information Contact
800-451-0525 Ext. 1608
Manufacturer Reason
for Recall		Home communicator Model 7000L may not sense the phone line under certain unusual landline phone conditions.
FDA Determined
Cause 2		Software design
ActionPhilips 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 Commerce3189 devices total, 38 are subject to recall
DistributionNationwide Distribution including AK AZ CA CT FL IA IL KY MA MD MT NC NE NH NY OH OR SC VA WA and WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = ILQ
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