# FDA recall Z-1152-2024

> **PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.** · Class II · device recall initiated 2024-01-02.

## Product

Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system.    Affected PCs: XRay PC, Suite PC, and FlexViewing PC    Azurion Model Name - Model Number:    Azurion 3 M12  722063  722221;  Azurion 3 M15  722064  722222;  Azurion 5 M20  722228;  Azurion 7 B12  722067  722225;  Azurion 7 B20  722068  722226;  Azurion 7 M12  722078  722223;  Azurion 7 M20  722079  722224;

## Reason for recall

Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.

## Distribution

Worldwide Distribution: US nationwide including states of: AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, & WY; and OUS (International) to countries of: Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Greece, Guadeloupe, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macedonia, 

## Key facts

- **Recall number:** Z-1152-2024
- **Recalling firm:** PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-02
- **Report date:** 2024-02-28

- **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-1152-2024

## Citation

> AI Analytics. FDA recall Z-1152-2024. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1152-2024. Source: US FDA. Licensed CC0.

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