Recall Z-0004-2016 ยท ILQ System, Communication, Powered
Lifeline Systems, Incorporated
Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System.
| Date | Oct 1, 2015 (initiated Jul 23, 2015) |
| Status | Terminated |
| Reason | Irregular battery disconnection resulted in issues with Mobile Health Button (MHB) Charging. |
| Root 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 replac |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K914103 | LIFELINE(R) PERSONAL RESPONSE SYSTEM Lifeline Systems, Inc., Sep 27, 1991 |