# FDA recall Z-2288-2026

> **PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.** · Class II · device recall initiated 2023-12-07.

## Product

Philips Azurion 7B12/12, Model Numbers:  722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

## Reason for recall

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable.  The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2288-2026
- **Recalling firm:** PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-07
- **Report date:** 2026-06-10

- **Voluntary/Mandated:** 
- **Location:** Best, Netherlands

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2288-2026

## Citation

> MORVS. FDA recall Z-2288-2026. Retrieved 2026-10-21 from https://api.morvs.ai/recall/Z-2288-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*