Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, ...
FDA Device Recall #Z-2199-2019 — Class II — April 29, 2019
Recall Summary
| Recall Number | Z-2199-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 29, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Ultrasound Inc |
| Location | Bothell, WA |
| Product Type | Devices |
| Quantity | 3,146 devices |
Product Description
Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70. Product Usage: The intended use of the EPIQ, EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Or Jan (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal. When integrated with Philips EchoNavigator, the systems can assist the interventionist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance.
Reason for Recall
There is a potential that the image of one patient could get unexpectedly moved into another patient's folder when the user is using the Edit functionality on the Patient Data Entry (PDE) screen of the device.
Distribution Pattern
Worldwide Distribution - US Nationwide, including Puerto Rico. There was also military/government distribution. Foreign distribution was made to Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Latvia, Luxembourg, Malaysia, Mayotte, Mexico, Monaco, Morocco, Netherlands, New Zealand, Nicaragua, Norway, Oman, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United Kingdom Virgin Islands, Uruguay, and Viet Nam.
Lot / Code Information
All models containing software version 4.0.
Other Recalls from Philips Ultrasound Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0123-2022 | Class II | EPIQ CVxi Diagnostic Ultrasound Systems, Produc... | Sep 21, 2021 |
| Z-0070-2022 | Class II | Philips Ultrasound, Inc. Sparq, Diagnostic Ultr... | Aug 19, 2021 |
| Z-0071-2022 | Class II | Philips Ultrasound, Inc. Sparq, Diagnostic Ultr... | Aug 19, 2021 |
| Z-2483-2021 | Class II | EPIQ Diagnostic Ultrasound Systems: Software... | Aug 6, 2021 |
| Z-2484-2021 | Class II | Affiniti Diagnostic Ultrasound Systems: Soft... | Aug 6, 2021 |
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.