# FDA recall Z-0284-2024

> **Philips Ultrasound, Inc.** · Class II · device recall initiated 2023-10-09.

## Product

Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210

## Reason for recall

Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image.

## Distribution

US: AZ, CA, CT, FL, GA, ID, IL, KY, MD, MT, NE, NV, OH, TN, TX, UT, VA OUS: Canada

## Key facts

- **Recall number:** Z-0284-2024
- **Recalling firm:** Philips Ultrasound, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2023-10-09
- **Report date:** 2023-11-15

- **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-0284-2024

## Citation

> AI Analytics. FDA recall Z-0284-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0284-2024. Source: US FDA. Licensed CC0.

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