Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Philips GoSafe Communicator 7000L Personal emergency response system.

FDA Recall Z-1987-2015 · Posted 2015-07-06

Recalling FirmLifeline Systems, Incorporated
Recall StatusTerminated
Product CodeILQ
Date Initiated2015-04-22
Date Terminated2016-08-24
Product Quantity3189 devices total, 38 are subject to recall

Reason for Recall

Home communicator Model 7000L may not sense the phone line under certain unusual landline phone conditions.

Firm 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.

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K914103LIFELINE(R) PERSONAL RESPONSE SYSTEMLifeline Systems, Inc. · 1991-09-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑