Skip to content
Get alerts
GovInfoNow
Use caution Medical device recall · FDA · Published August 19, 2021

Philips Sparq Ultrasound System Recall: Battery Shutdown Risk

Philips recalls Sparq diagnostic ultrasound systems with battery data issues causing intermittent shutdowns. Affected units have specific serial numbers. Contact Philips for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0071-2022Medical devicePhilips ›
Take action

Contact the company

Recalling firmPhilips Ultrasound Inc22100 Bothell Everett Hwy · Bothell, WA 98021-8431
✎ GovInfoNow plain-language explainer

Philips is recalling Sparq diagnostic ultrasound systems that may shut down unexpectedly due to battery data issues. This could disrupt medical use and requires immediate attention from healthcare providers. Read more at govinfonow.com/recall/61922-philips-sparq-ultrasound-system-recall-battery-shutdown-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/61922-philips-sparq-ultrasound-system-recall-battery-shutdown-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0071-2022

Cite this page

“Philips Sparq Ultrasound System Recall: Battery Shutdown Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61922-philips-sparq-ultrasound-system-recall-battery-shutdown-risk. Based on FDA recall #Z-0071-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0071-2022%22&limit=1).

The FDA announced on Aug. 19, 2021, that Philips Ultrasound Inc. is recalling one Sparq Diagnostic Ultrasound System due to a battery system data issue that can cause intermittent shutdowns. The agency issued recall number Z-0071-2022 for the Class II voluntary recall.

How to tell if you have it

  • Brand: Philips
  • Product: Sparq, Diagnostic Ultrasound System
  • REF: 795116
  • UPC: 00884838098015
  • Serial Number/UDI: US92010594 (01)00884838098015(21)US92010594

The hazard

According to the FDA, a 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.

Context

GovInfoNow's records show Philips Ultrasound, Inc. has 14 other recalls on record since April 29, 2019. Recent brand recalls include the Sept. 5, 2025 Philips S5-1 Ultrasound Transducer Recall and the July 3, 2025 Philips Ultrasound C10-3v Transducer Probe Recall, both addressing useful life clarification. Other recent recalls of similar products include the Dec. 15, 2025 Philips Allura Xper FD10C Medical System Recall and the Nov. 14, 2025 GE Healthcare Carestation Anesthesia System Power Board Recall.

How to tell if you have this one

Check for the serial number US92010594 on the device. The affected units have specific model numbers and were sold with the REF 795116 designation.

  • Brand
    Philips
  • Product
    Philips Ultrasound Inc recalls Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • 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.
Recall numberProduct, codes & lotsQuantity
Z-0070-2022Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,; Affected Serial Numbers/UDI numbers: USD1410130 /N/A, US12110905 /(01)00884838097971(21)US12110905, US12110906 /(01)00884838097971(21)US12110906, US12111049 /(01)00884838097971(21)US12111049, US31310191 /N/A, US31511242 /N/A, US32111072 /(01)00884838097971(21)US32111072, US41210049 /N/A, US42111774 /(01)00884838097971(21)US42111774, US51210186 /N/A, US62011642 /(01)00884838028098(21)US62011642, US71810505 /(01)00884838028098(21)US71810505, US72011713 /(01)00884838028098(21)US72011713, US72011714 /(01)00884838028098(21)US72011714, US82010111 /(01)00884838028098(21)US82010111, US91410757 /N/A, US92010327 /(01)00884838028098(21)US92010327, US92010512 /(01)00884838028098(21)US92010512, USD2011313 /(01)00884838097971(21)USD2011313, USD2011314 /(01)00884838097971(21)USD2011314, USD2011362 /(01)00884838097971(21)USD2011362, USD2011363 /(01)00884838097971(21)USD2011363, USD2011480 /(01)00884838097971(21)USD2011480, USD2011481 /(01)00884838097971(21)USD2011481, USD2011482 /(01)00884838097971(21)USD2011482, USD2011483 /(01)00884838097971(21)USD2011483, USD2011578 /(01)00884838097971(21)USD2011578, USD2011622 /(01)00884838097971(21)USD2011622, USD2011623 /(01)00884838097971(21)USD2011623, USN1510828 /N/A, USN2011691 /(01)00884838097971(21)USN2011691, USO1210225 /N/A, USO2011257 /(01)00884838097971(21)USO2011257, USO2012052/ (01)00884838097971(21)USO201205234 units
Z-0071-2022Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,; Affected Serial Number/UDI numbers: US92010594 (01)00884838098015(21)US920105941 unit
Based on the official FDA remedy

What to do — step by step

  1. Check Device Status

    Verify if the ultrasound system shuts down unexpectedly despite battery or AC power being connected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 10 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: named in the noticeMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Maryland, Massachusetts, Michigan, Mississippi, New York, North Carolina, Ohio, Virginia, Washington.

Recall timeline

FDA terminated this recall 3 years after the firm started it.

1. Firm started the recall: Aug 19, 202112. FDA classified it Class II: Oct 7, 202123. Published in FDA’s Enforcement Report: Oct 13, 202134. FDA terminated the recall: Sep 6, 2024420212024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Safeguard US Recalls Battle Bandages and IFAK Kits Due to Infection Risk
Safeguard US Operating LLCMiniMed Flex Insulin Pump Recall: Inaccurate Delivery Risk
Medtronic MiniMed, Inc.Medline Bariatric Rollator Recall: Detaching Wheels Risk
Medline Industries, LPCooperVision Pearle Vision 1 Day Contact Lenses: Incorrect Power Risk
CooperVision, Inc.Tandem t:slim App Recall: Pairing Issue With Abbott Sensors
Tandem Diabetes Care, Inc.

Latest medical device recalls

BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600
BMC Medical Co., Ltd. · July 15, 2026Medtronic MiniMed, Inc. recalls MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Medtr: MiniMed · July 13, 2026INTEGRATED MEDCRAFT LLC recalls Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway
Medcraft · July 7, 2026Pride Mobility Products Corp. recalls Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version:
Quantum Rehab · June 25, 2026ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory
ResMed · June 25, 2026Therabody, Inc recalls Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO
Therabody · June 23, 2026

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0071-2022 (August 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0071-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA