# FDA recall Z-1130-2019

> **Philips North  America, LLC** · Class II · device recall initiated 2019-03-12.

## Product

Azurion FlexArm, 722079

## Reason for recall

During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not according to specification. This resulted in damage of the 24V power cable of the detector.

## Distribution

Distributed to one account in Florida, and one international account in Germany.

## Key facts

- **Recall number:** Z-1130-2019
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-12
- **Report date:** 2019-04-17
- **Termination date:** 2020-10-07

- **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-1130-2019

## Citation

> AI Analytics. FDA recall Z-1130-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1130-2019. Source: US FDA. Licensed CC0.

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