# FDA recall Z-1809-2020

> **Philips North  America, LLC** · Class II · device recall initiated 2020-04-03.

## Product

Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the  Azurion R2.0 system         Interventional fluoroscopic x-ray system   System code:  722079

## Reason for recall

When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGuide guidance step and moves the L-arm away from the initial scan position before starting the live guidance, a warning message directs the user to move the L-arm stand back to the initial XperCT scan position. Although the software generates this message, it does not prevent the use of live guidance if the L-arm stand is not repositioned. Using live guidance with a mispositioned L-arm can result in the display of an incorrect overlay and needle path.

## Distribution

Worldwide distribution.  US states of FL, ID, IL, IN, MA, and OH, Canada, Australia, Austria, Belgium, Germany, and Netherlands  New Zealand, South Africa, Switzerland, Thailand

## Key facts

- **Recall number:** Z-1809-2020
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-03
- **Report date:** 2020-05-06
- **Termination date:** 2023-02-01

- **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-1809-2020

## Citation

> AI Analytics. FDA recall Z-1809-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1809-2020. Source: US FDA. Licensed CC0.

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