# FDA recall Z-1647-2023

> **PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.** · Class II · device recall initiated 2023-03-21.

## Product

Philips Azurion System  with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6.  Models/Model Number:   (1) Azurion 3M12:	722063, 722221;  (2) Azurion 3M15:	722064, 722222;  (3) Azurion SM12:	722227;  (4) Azurion SM20:	722228;  (5) Azurion 7B12/12: 722067, 722225;  (6) Azurion 7820/15:	722068, 722226;  (7) Azurion 7M12:	722078, 722223;  (8) Azurion 7M20	:	722079, 722224

## Reason for recall

Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available  there will be a sudden interruption of the procedure

## Distribution

Nationwide  Foreign: Algeria Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Cambodia Chile China Colombia Costa Rica C¿te D'Ivoire Croatia Cyprus Czech Republic Denmark Dominican Rep Ecuador Egypt Estonia Finland France French Polynesia Germany Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Kosovo Kuwait Latvia Lebanon Lithuania Macao Macedonia Malaysia Mexico Morocco Myanmar Nepal Netherlands New Zealand Nicaragua Nigeria Norway Oman Pakistan Palestine Palestine, State of Panama Peru Philippines Poland Portugal Puerto Rico Qatar Romania Russian Federation Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa South Korea Spain Sri Lanka Sweden Switzerland Taiwan Thailand Tunisia Turkey Turkmenistan Ukraine United Kingdom Utd.Arab.Emir. Uzbekistan Vietnam Yemen

## Key facts

- **Recall number:** Z-1647-2023
- **Recalling firm:** PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-21
- **Report date:** 2023-06-07

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1647-2023

## Citation

> AI Analytics. FDA recall Z-1647-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1647-2023. Source: US FDA. Licensed CC0.

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