Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 70...
FDA Device Recall #Z-1140-2019 — Class II — February 19, 2019
Recall Summary
| Recall Number | Z-1140-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 19, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Medical Systems Nederlands |
| Location | Best, N/A |
| Product Type | Devices |
| Quantity | 7209 total |
Product Description
Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.
Reason for Recall
Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or continuous inability of making live fluoroscopy images or exposures.
Distribution Pattern
US Nationwide Distribution in the states of CA, FL, MI, OR, PA, TX and WA.
Lot / Code Information
Foot Switches: 452270000141 Footswitch CV 3p 4m; 452270000151 Footswitch MD 3p 6m; 452270000142 Footswitch CV 3p 4m; 452270000381 Footswitch CV 3p 8m; 452270000382 Footswitch CV 3p 8m; 459800076001 Footswitch CV 4p+2 4m; 459800076021 Footswitch CV 4p+2 8m; 459800415571 Wireless Footswitch 4p+2; 459800415581 Wireless footswitch set 4p+2; 459800415531 Wireless Footswitch 3P; 459800415561 Wireless footswitch set 3P.
Other Recalls from Philips Medical Systems Nederlands
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1240-2019 | Class II | Ingenia Ambition S (781359), Ingenia Ambition X... | Mar 25, 2019 |
| Z-1141-2019 | Class II | Foot Switches used with the following systems: ... | Feb 19, 2019 |
| Z-0908-2019 | Class II | Intera 1.5T High Performance, Model Number 7812... | Dec 21, 2018 |
| Z-0903-2019 | Class II | SmartPath to dStream for XR and 3.0T, Model Num... | Dec 21, 2018 |
| Z-0890-2019 | Class II | Intera 1.5T Achieva CV Nova, Model Number 78117... | Dec 21, 2018 |
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.