Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System.
FDA Recall Z-0004-2016 · Posted 2015-10-01
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Recalling FirmLifeline Systems, Incorporated
Recall StatusTerminated
Product CodeILQ
Date Initiated2015-07-23
Date Terminated2020-11-10
Product Quantity8,616 devices
Reason for Recall
Irregular battery disconnection resulted in issues with Mobile Health Button (MHB) Charging.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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