Class 2 Device Recall Philips GoSafe Mobile Help Button 7000MHB

• Date Initiated by Firm: July 23, 2015
• Date Posted: October 01, 2015
• Recall Status: Terminated on November 10, 2020
• Recall Number: Z-0004-2016
• Recall Event ID: 71858
• 510(K)Number: K914103
• Product Classification: System, communication, powered - Product Code ILQ
• Product: Philips GoSafe Mobile Help Button; 7000MHB.; ; Personal Emergency Response System.
• Code Information: Serial Numbers: 1030000887 1030000931 1030000934 1030000993 1030001039 1030001057 1030001059 1030001173 1030001182 1030001210 1030001226 1030001254 1030001292 1030001315 1030001318 1030001358 1030001371 1030001441 1030001460 1030001526 1030001528 1030001568 1030001640 1030001641 1030001710 1030001720 1030001743 1030001797 1030001807 1030001819 1030002013 1030002025 1030002051 1030002129 1030002185 1030002214 1030002225 1030002233 1030002252 1030002316 1030002331 1030002406 1030002413 1030002444 1030002458 1030002489 1030002524 1030002534 1030002582 1030002601 1030002622 1030002626 1030002638 1030002669 1030002673 1030002689 1030002690 1030002715 1030002736 1030002755 1030002764 1030002881 1030002886 1030002889 1030002890 1030002904 1030002905 1030002924 1030002942 1030002946 1030002947 1030002969 1030002975 1030003005 1030003013 1030003015 1030003044 1030003077 1030003098 1030003143 1030003186 1030003284 1030003308 1030003314 1030003316 1030003392 1030003413 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• 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: Irregular battery disconnection resulted in issues with Mobile Health Button (MHB) Charging.
• FDA Determined Cause: Process control
• Action: Customers were also notified of the recall via an Urgent: Medical Device Recall sent, by US Mail, between 8/19/2015 and 8/20/2015. The letter described the reason for the recall and how to recognize the device failure. The customer is asked to do the following: 1. Review and confirm the attached list of affected units for your program. Contact the affected subscribers listed and notify them that a service visit will be scheduled so that their units can be replaced within the next few weeks. 2. If any subscribers report any issues with their MHB, contact Philips for an expedited unit replacement and instruct them to discontinue use. 3. Philips Customer Care will follow-up with customers via telephone to ensure that they have received and understood the notification. During this follow-up call, we will also confirm arrangements for unit replacements.
• Quantity in Commerce: 8,616 devices
• Distribution: Nationwide Distribution -- AK, AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, MA, MD, MI, MN, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TX, UT, VA, VT, WA, and WI.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = ILQ and Original Applicant = LIFELINE SYSTEMS, INC.