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FDA (Device enforcement)Recalled 2021-08-19closedclass ii

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

Is my product affected?

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

  • UPC 00884838098015

Check against the official notice below — it lists the full affected range.

What happened

Philips Ultrasound Inc. has recalled the Philips Ultrasound Sparq Diagnostic Ultrasound System (model REF 795116) due to a battery system data issue. The defect can cause the ultrasound system to shut down unexpectedly at any time, even when the battery is fully charged or when the device is plugged into alternating current power. One unit with serial number US92010594 has been identified as affected and was distributed worldwide, including across the United States and several international locations.

The recall notice does not specify a remedy for consumers who have this device.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. 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. Quantity: 1 unit Lot/code info: Affected Serial Number/UDI numbers: US92010594 (01)00884838098015(21)US92010594

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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