# FDA recall Z-2338-2020

> **Philips Healthcare Informatics, Inc.** · Class II · device recall initiated 2019-04-19.

## Product

IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.

## Reason for recall

Images may potentially become corrupt while using the system.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, FL, LA, MA, MI, MO, NC, NH, NY, OR, and TX.  There was government distribution but no military distribution.  The countries of Canada, Brazil, Ireland, New Zealand, United Arab Emirates, and the United Kingdom.

## Key facts

- **Recall number:** Z-2338-2020
- **Recalling firm:** Philips Healthcare Informatics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2019-04-19
- **Report date:** 2020-06-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pleasanton, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2338-2020

## Citation

> AI Analytics. FDA recall Z-2338-2020. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-2338-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*