Z-1007-2026Class II

Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF...

Name: Z-1007-2026 Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF...
Creator: Philips Ultrasound, LLC
Published: 2022-07-14
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2022-07-14 / Completed / root cause: software

FDA source

Philips Ultrasound, LLC began a recall of Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117... on 2022-07-14. FDA classified it as Class II and gives the reason as "Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as software.

Recall record

Recall number: Z-1007-2026
Classification: Class II
Status: Completed
Initiated: 2022-07-14
Posted: 2025-12-31
Recalling firm: Philips North America LLC
Product: Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.
Root cause tag: software
FDA root cause: Software Design Change
Action: On July 18, 2022, Phillips issued a product notification to affected consignees. Philips ask consignees to take the following actions: 1. If the X5-1c transducer is connected to the right-most port (when viewing from the front), this problem will not occur. Please ensure your X5-1c is connected to the right-most connector until the software update (FCO79500561) has been installed. 2. Please retain this letter with your product documentation until the software update (FCO79500561) has been implemented on your system. 3. Please circulate this notice to all users of this device so that they are aware of the issue. 4. A Philips Field Service Engineer will contact you to schedule the installation of the software update to resolve this issue (reference FCO79500561).
Quantity in commerce: 1,721 systems
Distribution: Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Argentina, Australia, Belgium, Canada, Chile, Colombia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Korea, Republic of Latvia, Lithuania, Morocco, Netherlands , New Zealand, Oman, Panama, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom.
Product codes and lots: Software Version Numbers: 9.0, 9.01, 9.02 795234/UDI: (01)00884838107540 795232/UDI: (01)00884838107533 795231/ UDI: (01)00884838097933 795201/UDI: (01)00884838047693 795200/ UDI: (01)00884838107441 795122/ UDI: (01)00884838097933 795117/ UDI: (01)00884838047693

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1007-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1007-2026	Class II	Completed	Voluntary: Firm initiated	2026-01-07	2025-12-31

Product code IYN

K231190Class IIEPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC / cleared 2023-05-12

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)