Z-0944-2021Class II

Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C...

Name: Z-0944-2021 Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C...
Creator: Philips Ultrasound Inc
Published: 2020-12-16
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2020-12-16 / Terminated / root cause: manufacturing process

FDA source

Philips Ultrasound Inc began a recall of 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... on 2020-12-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0944-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-16
Posted: 2021-02-02
Terminated: 2023-03-15
Recalling firm: Philips North America LLC
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
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: 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 tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 607 units
Distribution: 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.
Product codes and lots: All EPIQ Systems with software version 7.0 Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0944-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0944-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-10	2021-02-01

Product code IYN

K182857Class IIEPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. / cleared 2018-11-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)