# FDA recall Z-1145-2020

> **Philips North  America, LLC** · Class II · device recall initiated 2019-12-23.

## Product

VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20.  System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extensions Azurion 7 series (722136),  Allura Xper R9 (722303).    The product is software, used during an endovascular intervention procedure.

## Reason for recall

Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselNavigator application, the DSA is displayed without subtraction.

## Distribution

Worldwide Distribution.  US nationwide, Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Latvia, Libya, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Reunion, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Uruguay.

## Key facts

- **Recall number:** Z-1145-2020
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-23
- **Report date:** 2020-02-19
- **Termination date:** 2022-11-17

- **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-1145-2020

## Citation

> AI Analytics. FDA recall Z-1145-2020. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1145-2020. Source: US FDA. Licensed CC0.

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