FDA Medical Device Recalls (openFDA)
Philips Ultrasound Inc: Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only
- Recall number
- Z-0071-2022
- Recalling firm
- Philips Ultrasound Inc
- Product
- Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
- Status
- Terminated
- Initiated
- 2021-08-19
- Posted
- not on file
- Terminated
- 2024-09-06
- Reason
- 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
- 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: ultrasound.corrections@philips.com, 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
- 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.
- Lot, serial or model codes
- Affected Serial Number/UDI numbers: US92010594 (01)00884838098015(21)US92010594
- 510(k) numbers
- ["K201012"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 3019216
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28