# FDA recall Z-2483-2021

> **Philips Ultrasound Inc** · Class II · device recall initiated 2021-08-06.

## Product

EPIQ Diagnostic Ultrasound Systems:    Software Versions 5.0, 5.0.1 and 5.0.2    Models:  EPIQ 5 - 795120  EPIQ 5C - 795205  EPIQ 5G - 795204  EPIQ 7 - 795117  EPIQ 7C - 795201  EPIQ 7G - 795200  EPIQ CVxi -795232   EPIQ CVx - 795231

## Reason for recall

Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.

## Distribution

Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Albania, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Brazil, Brunei Darussalam, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, Germany, Gibraltar, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanm

## Key facts

- **Recall number:** Z-2483-2021
- **Recalling firm:** Philips Ultrasound Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2021-08-06
- **Report date:** 2021-09-29

- **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-2483-2021

## Citation

> AI Analytics. FDA recall Z-2483-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2483-2021. Source: US FDA. Licensed CC0.

---

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