—#204164

Product

Allura Xper IGTS Fixed Systems

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K141979
Affected lot / code info: Allura Xper FD10 285 Allura Xper FD10 1517 Allura Xper FD10 1634 Allura Xper FD10 177 Allura Xper FD10 764 ALLURA Xper FD10 C 249 Allura Xper FD20 2013 Allura Xper FD20 1334 Allura Xper FD20 1473 Allura Xper FD20 2110 Allura Xper FD20 2155 Allura Xper FD20 919 Allura Xper FD20 1581 Allura Xper FD20 2353 Allura Xper FD20 1811 Allura Xper FD20 2087 Allura Xper FD20 53364 Allura Xper FD20/15 172

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 #204164. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.