# FDA recall Z-2205-2019

> **Philips North  America, LLC** · Class II · device recall initiated 2019-07-16.

## Product

Philips Azurion systems with software  version R1.2  -Interventional Fluoroscopic X-ray system as follows:   Azurion 3 M12, Azurion 3 M15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20  Models: 722063, 722064, 722067, 722068, 722078, 722079.      Product Usage:  The Azurion series (within the limits of the used Operating Room table) are intended for use to perform:   Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures   Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally:   . The Azurion series can be used in a hybrid Operating Room.   The Azurion series contain a number of features to support a flexible and patient centric procedural workflow.

## Reason for recall

The cold restart of Azurion R1.2 systems may take up to 7 minutes if the system is connected to the mains power supply for more than 50 days, may result in a delay of treatment.

## Distribution

US Nationwide Distribution   Foreign:  Canada  Argentina  AUSTRALIA  Austria  Azerbaijan  Bahrain  Bangladesh  Belgium  Bosnia and Herzegovina  Brazil  Bulgaria  Chile  Colombia  CROATIA  Denmark  ECUADOR  Egypt  Finland  France  Germany  Greece  Hong Kong  India  Indonesia  Ireland  Israel  Italie  Italy  Japan  Jordan  Kazakhstan  Korea, Republic of  Latvia  Lebanon  Libya  Malaysia  Maldives  Mexico  Mongolia  Myanmar  Netherlands  New Zealand  Norway  Oman  Pakistan  Philippines  Polamnd  Poland  Portugal  Republic of Korea  Romania  Russian Federation  Saudi Arabia  Serbia  Singapore  SLOVENIA  South Africa  Spain  Sri Lanka  Sweden  Switzerland  Thailand  Tunisia  Turkey  UNITED ARAB EMI  United Arab Emirates  United Kingdom  Uzbekistan  Viet Nam

## Key facts

- **Recall number:** Z-2205-2019
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-16
- **Report date:** 2019-08-14
- **Termination date:** 2020-06-04

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2205-2019

## Citation

> AI Analytics. FDA recall Z-2205-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2205-2019. Source: US FDA. Licensed CC0.

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