Philips GoSafe Communicator 7000L Personal emergency response system.
FDA Device Recall #Z-1987-2015 — Class II — April 22, 2015
Recall Summary
| Recall Number | Z-1987-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 22, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Lifeline Systems, Incorporated |
| Location | Framingham, MA |
| Product Type | Devices |
| Quantity | 3189 devices total, 38 are subject to recall |
Product Description
Philips GoSafe Communicator 7000L Personal emergency response system.
Reason for Recall
Home communicator Model 7000L may not sense the phone line under certain unusual landline phone conditions.
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.
Lot / Code Information
Serial Numbers: 9030003931 9030001761 9030002025 9030002242 9030001588 9030000853 9030001696 9030003178 9030003086 9030000589 9030001526 9030003837 9030000681 9030003507 9030000600 9030001060 9030001517 9030004154 9030002875
Other Recalls from Lifeline Systems, Incorporated
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0004-2016 | Class II | Philips GoSafe Mobile Help Button; 7000MHB. ... | Jul 23, 2015 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.