Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System.
FDA device recall Z-0004-2016 · posted 2015-10-01 · Terminated
Recall details
- Recalling firm
- Lifeline Systems, Incorporated
- Reason for recall
- Irregular battery disconnection resulted in issues with Mobile Health Button (MHB) Charging.
- Action taken
- 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
- Status
- Terminated
- Product code
- ILQ
- Quantity affected
- 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.
- Date initiated
- 2015-07-23
- Date posted
- 2015-10-01
- Date terminated
- 2020-11-10
- Location
- Framingham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFELINE(R) PERSONAL RESPONSE SYSTEM (K914103) | Lifeline Systems, Inc. | 1991-09-27 |