# FDA recall Z-1176-2024

> **PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.** · Class II · device recall initiated 2024-02-06.

## Product

Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures   Models:   (1) 722221  (2) 722222  (3) 722280

## Reason for recall

Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of NY, PA, PR, TN, TX, VA, WA and the countries of Algeria, Armenia, Austria, Brazil, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Hungary, India, Indonesia, Iraq, Israel,  Italy, Japan, Kazakhstan, Korea, Republic of Kuwait, Lithuania, Macao, Macedonia,  Malaysia, Morocco, Netherlands, Norway, Oman, Palestine, State of Panama, Poland,  Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Saudi Arabia, Spain,  Sweden, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, United Kingdom.

## Key facts

- **Recall number:** Z-1176-2024
- **Recalling firm:** PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-06
- **Report date:** 2024-02-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Best, N/A, Netherlands

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1176-2024

## Citation

> AI Analytics. FDA recall Z-1176-2024. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-1176-2024. Source: US FDA. Licensed CC0.

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