# FDA recall Z-0357-2022

> **Philips North America Llc** · Class II · device recall initiated 2021-11-12.

## Product

Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. .  Model Number: 718132

## Reason for recall

Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns

## Distribution

Worldwide distribution - US Nationwide and the countries of Afghanistan, Algeria, American Samoa, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cameroon, Chile, China, Colombia, Cook Islands, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Faroe Islands, Finland, France, French Guiana, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guyana, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan,  Kazakhstan, Kenya, Korea, Republic of Kuwait, Lao People's Democratic Republic,  Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Malaysia, Maldives Mali, Martinique, Mauritius, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar,  Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan,  Palestine, State of Panama, Papua New Guinea, Peru, Philippines, Poland, Portugal,  

## Key facts

- **Recall number:** Z-0357-2022
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-11-12
- **Report date:** 2021-12-15

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0357-2022

## Citation

> AI Analytics. FDA recall Z-0357-2022. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-0357-2022. Source: US FDA. Licensed CC0.

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