FDA (Devices) recall action 93342
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
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.
The agency’s own wording, quoted from the enforcement report.
Philips is recalling Integris-Allura IGTS Fixed Systems delivered to Puerto Rico, Guam, and the Virgin Islands due to missing Source-to-Skin Distance Spacers and required warning labels.
Philips has recalled certain surgical C-arm imaging systems delivered to Puerto Rico because they lack required warning labels and are missing a critical Source-to-Skin Distance Spacer component.
Philips Azurion IGTS Fixed Systems delivered to U.S. territories lack required safety components. The Source-to-Skin Distance Spacer and warning label are missing from affected units.
Philips is recalling Zenition 50 & 70 surgical C-arm systems distributed to Puerto Rico, Guam, and the Virgin Islands due to missing warning labels and safety spacers. These missing components may compromise radiation safety during surgical use.
Philips X-ray imaging systems delivered to Puerto Rico are missing warning labels and Source-to-Skin Distance Spacers. These missing safety components could affect user safety during imaging procedures.
Philips recalled surgical C-arm systems in US territories without required warning labels and missing the Source-to-Skin Distance Spacer. Facilities should contact Philips for instructions on obtaining missing components.