Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Recalled by Philips Ultrasound Inc Due to There is a potential that the image of...

Date: April 29, 2019
Company: Philips Ultrasound Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Philips Ultrasound Inc directly.

Affected Products

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.

Quantity: 3,146 devices

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Philips Ultrasound Inc

Philips Ultrasound Inc has 14 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report