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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 1
Distribution
Part of a larger recall action
This product is one of 2 recalled by Philips Ultrasound Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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