The Recall Desk
HighFDA (Devices)·Z-0071-2022·Announced 2021-10-13

Philips Ultrasound Sparq System Recalled Due to Intermittent Shutdown Risk

Philips Ultrasound recalls the Sparq diagnostic ultrasound system due to a battery system data issue causing intermittent device shutdowns, regardless of actual battery status or AC power connection. Affected units were distributed in 10 US states and internationally.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a medical device with risk-of-harm potential. The battery system data issue could cause unexpected system shutdown during patient diagnostic procedures. No injuries or hospitalizations are reported in the source text, warranting a High severity classification.

Plain-English summary

Philips Ultrasound, Inc. is recalling the Sparq Diagnostic Ultrasound System (REF 795116) due to a battery system data issue. The issue can cause the ultrasound system to shut down intermittently without warning, regardless of actual battery status or whether the device is connected to alternating current power.

The affected units were distributed worldwide, including across multiple US states (California, Massachusetts, Maryland, Michigan, Mississippi, North Carolina, New York, Ohio, Virginia, and Washington) and internationally to Australia, Portugal, Netherlands, Canada, and Germany. Affected units can be identified by serial number US92010594.

Users of affected devices should contact Philips Ultrasound for guidance regarding corrective actions and verification of their device's serial number.

The recalled product

Product
Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
Manufacturer
Philips Ultrasound Inc
Category
Medical Device — Diagnostic Ultrasound System
Hazard
  • system-shutdown
  • battery-failure

Distribution

Distributed nationwide across the United States.

Related recalls

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