Z-0071-2022Class II

Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA...

Name: Z-0071-2022 Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA...
Creator: Philips Ultrasound Inc
Published: 2021-08-19
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2021-08-19 / Terminated / root cause: software

FDA source

Philips Ultrasound Inc began a recall of Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only on 2021-08-19. FDA classified it as Class II and gives the reason as "Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of alternating current power". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0071-2022
Classification: Class II
Status: Terminated
Initiated: 2021-08-19
Posted: 2021-10-07
Terminated: 2024-09-06
Recalling firm: Philips North America LLC
Product: Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of alternating current power.
Root cause tag: software
FDA root cause: Software design
Action: On August 24, 2021, Philips issued "Urgent Medical device Correction" notification to affected consignees. The customer communication was distributed via: USPS Certified Mail In addition to informing consignees about the recall, Philips requested consignees take the following actions: Instructions for how to determine the software version of your Ultrasound system: 1. Power up the system and allow it to complete the boot sequence, 2. Press the Wrench icon on the upper right side of the control panel, 3. Press the Service button on the bottom left corner, 4. Under System Management, Press System Information, 5. The software version is listed in the Software Information Section. 4. Describe the actions that should be taken by the customer / user in order to prevent risks for patients or users A. If this shutdown occurs, Philips recommends that the system be put back on AC power and restarted. The system will be fully functional upon restart. However, restarting the system will not prevent the possibility of the issue reoccurring. B. Please complete and return the attached form to Philips promptly and no later than 30 days from receipt (via email: [email protected], or fax: 1-833-512-7756). 5. Describe the actions planned by Philips Ultrasound to correct the problem A Philips Field Service Engineer will contact you to schedule a software update to permanently resolve the issue (reference FCO79500550). 6. This notice has been reported to the appropriate Regulatory Agencies. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, or by regular mail, or by fax. 7. Please be assured that maintaining a high level of safety and quality is our highest priority. If you need any further information or support concerning this issue, please contact your local Philips representative: 1-800-722-9377 and reference FCO79500550.
Quantity in commerce: 1 unit
Distribution: Worldwide distribution - US Nationwide distribution in the states of CA, MA, MD, MI, MS, NC, NY, OH, VA, WA and the countries of Australia, Portugal, Netherlands, Canada, Netherlands, Germany.
Product codes and lots: Affected Serial Number/UDI numbers: US92010594 (01)00884838098015(21)US92010594

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0071-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0070-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-13	2021-10-07
Z-0071-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-13	2021-10-07

Product code IYN

K201012Class IIEPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. / cleared 2020-05-01

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)