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Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,

Class I - Dangerous
🏥 Medical Devices Recalled: August 19, 2021 Philips Ultrasound Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Affected Serial Number/UDI numbers: US92010594 (01)00884838098015(21)US92010594
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Philips Ultrasound Inc
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,

Product Codes/Lot Numbers:

Affected Serial Number/UDI numbers: US92010594 (01)00884838098015(21)US92010594

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0071-2022

Related Recalls

C6-2 Transducer Probe

Philips Ultrasound

Class I - Dangerous

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025 Other Medical Devices Nationwide View Details →