—#185039

Product

Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi. MOD EPIQ Elite DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only 100-240V~50/60 Hz, 600 VA MOD EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM; GMDN 40761, Rx Only, 100-240V~50/60 Hz, 600VA MOD EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM; GMDN 40761, Rx Only, 100-240V~50/60 Hz, 600VA MOD EPIQ DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only,100-240V~50/60 Hz, 600VA

FDA product code: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K182857
Affected lot / code info: All EPIQ Systems with software version 7.0 Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi

Why it was recalled

The manufacturer discovered an issue associated with the EPIQ Image Boost with xPlane and Color Flow or Doppler while using the X8-2t TEE Transducer. If Image Boost is enabled the color box shows flow visualization not accurately represent the fluid flow. Similarly, if Image Boost is enabled, both CW and PW Doppler traces will not accurately represent the fluid flow.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On 12/16/2020, the manufacturer sent an Urgent Medical Device Correction letter (MDC) with instructions on how to turn off the Image Boost feature. Philips will resolve the issue by providing a software update, at no cost, to correct all affected EPIQ Ultrasound Systems (the update will disable the Image Boost feature when connected to an X8-2t TEE Transducer). Method of Notification - Letter (Urgent Medical Device Correction Letter in the US, Field Safety Notice in rest of the world, Distributor Letter in rest of the world). For US customers, the letters will be sent via certify mail with electronic return receipt. Philips Markets Organizations are responsible for distributing the letters outside of the US.

Recalling firm

Firm: Philips Ultrasound Inc
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: US - AL, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE,NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI and WV OUS- Austria, Australia, Belgium, Canada, Chezh Republic, Croatia, Denmark, Egypt, Finland, France, Hong Kong, Indonesia, India, Ireland, Italy, Japan, Latvia, Lithuania, Malta, Mexico, Netherlands, Norway, Poland, Romania, Russia, Senegal, Slovenia, Sri Lanka, South Africa, Switzerland, Thailand, Turkey, UAE and United Kingdom.

Timeline

Recall initiated: 2020-12-16
Terminated: 2023-03-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185039. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.