# FDA recall Z-1348-2021

> **Fujifilm Medical Systems U.S.A., Inc.** · Class II · device recall initiated 2021-03-02.

## Product

Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server).

## Reason for recall

The wrong patient information may be displayed in the viewer or PowerJacket.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY and the countries of United Arab Emirates, Angola, Argentina, Austria, Australia, Belgium, Bermuda, Brazil, Canada, Switzerland, Chile, Colombia, Costa Rica, Czechia, Germany, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Indonesia, Israel, India, Italy, Jordan, Japan, Kuwait, Malta, Mexico, Malaysia, Netherlands, Peru, Philippines, Pakistan, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovenia, Slovakia, El Salvador, Thailand, Turkey, Uruguay, South Africa, Zimbabwe.

## Key facts

- **Recall number:** Z-1348-2021
- **Recalling firm:** Fujifilm Medical Systems U.S.A., Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-03-02
- **Report date:** 2021-04-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lexington, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1348-2021

## Citation

> AI Analytics. FDA recall Z-1348-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1348-2021. Source: US FDA. Licensed CC0.

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