The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0070-2022·Announced 2021-10-13

Philips Sparq Diagnostic Ultrasound System Battery Shutdown Issue

Certain Philips Sparq ultrasound systems may experience intermittent shutdowns due to a battery system data issue, potentially interrupting diagnostic procedures. Affected units have specific serial numbers and distribution includes multiple U.S. states.

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: FDA Class II medical device with risk of intermittent system shutdown during diagnostic procedures. No injuries or illnesses have been reported. This meets the rubric criterion for High severity: risk-of-harm medical product where injury has not yet been reported.

Plain-English summary

Philips Ultrasound Inc. has recalled 34 Sparq diagnostic ultrasound systems due to a battery system data issue. The affected systems can intermittently shut down regardless of actual battery state or whether alternating current power is applied, potentially interrupting diagnostic procedures.

The recall involves specific serial numbers distributed worldwide. In the United States, affected units are located in California, Massachusetts, Maryland, Michigan, Mississippi, North Carolina, New York, Ohio, Virginia, and Washington. The systems are also distributed in Australia, Portugal, Netherlands, Canada, and Germany.

Healthcare facilities with affected units should identify them by serial number and contact Philips Ultrasound Inc. for repair or replacement instructions. Continued use may result in unexpected system shutdowns during patient diagnostic procedures.

The recalled product

Product
Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
Manufacturer
Philips Ultrasound Inc
Category
Medical Device — Diagnostic Ultrasound
Hazard
Affected units
34

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

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.

See all 2 products in this recall →

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