# FDA recall Z-0071-2022

> **Philips Ultrasound Inc** · Class II · device recall initiated 2021-08-19.

## Product

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

## 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.

## Key facts

- **Recall number:** Z-0071-2022
- **Recalling firm:** Philips Ultrasound Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-08-19
- **Report date:** 2021-10-13
- **Termination date:** 2024-09-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bothell, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0071-2022

## Citation

> AI Analytics. FDA recall Z-0071-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0071-2022. Source: US FDA. Licensed CC0.

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