—#204163

Product

Integris-Allura IGTS Fixed Systems

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K002016
Affected lot / code info: INTEGRIS Allura 15-12 (mono) 68

Why it was recalled

Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.

Root cause (FDA determination)

Device Design

Recalling firm

Firm: Philips North America
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2296

Distribution

Distribution pattern: United States Territories of Puerto Rico, Guam, and Virgin Islands

Timeline

Recall initiated: 2023-10-04
Posted by FDA: 2024-09-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #204163. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.