# FDA recall Z-1113-2026

> **PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.** · Class II · device recall initiated 2025-12-12.

## Product

Philips Azurion system; Software Version Number: R3.1;

## Reason for recall

Philips has identified two (2) software issues affecting device systems that may result in loss of  imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content  and/or loss of data. Issue 1 - System remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error   Applicable only to systems with Poly-G3 frontal stand.

## Distribution

International distribution in the countries of AE, AR, AT, AZ, BE, BG, BH, BR, BS, CH, CL, CO, CR, CY, CZ, DE, DK, DZ, EC, EG, ES, GB, GR, GT, ID, IE, IL, IN, IQ, IT, JE, JP, LB, MA, MO, NI, NL, NO, PE, PL, RO, SA, SE, SV, TR, UA, VE, VN, ZA;

## Key facts

- **Recall number:** Z-1113-2026
- **Recalling firm:** PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-12
- **Report date:** 2026-01-28

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1113-2026

## Citation

> AI Analytics. FDA recall Z-1113-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1113-2026. Source: US FDA. Licensed CC0.

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