Philips Ultrasound Inc recalls Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC…

Recall date

April 29, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2199-2019

FDA classification

Class II

Brand / firm

Philips Ultrasound Inc

Sold / distributed

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, Denmar…

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.