Philips recalls Veradius Unity Mobile Surgery C-arms sold in Puerto Rico due to missing tube-spacer causing potential safety risks. Affected models include Veradius Neo 497, 607, and 619.
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.
Philips is recalling Veradius Unity Mobile Surgery C-arms sold in Puerto Rico because they lack a critical tube-spacer component. This missing part could lead to safety issues during medical procedures. Affected models include Ver: 497, 607, and 619.
The missing tube-spacer component could cause improper positioning during surgery, potentially leading to complications. Without this spacer, the device might not function correctly, increasing risks for patients and staff.
Medical professionals using Veradius Unity Mobile Surgery C-arms in Puerto Rico are most at risk. Patients undergoing procedures with these devices may also be affected.
Check for Veradius Unity Mobile Surgery C-arms with model numbers 497, 607, or 619 sold in Puerto Rico. The device may not have the required warning label.
Identify if your Veradius Unity Mobile Surgery C-arm has model numbers 497, 607, or 619 and was sold in Puerto Rico.
Philips has identified that some Veradius Unity Mobile Surgery C-arms delivered to Puerto Rico lack a warning label and the required tube-spacer component.
Veradius Neo 497, Veradius Neo 607, and Veradius Neo 619 models sold in Puerto Rico.
The recall does not specify a stop-use instruction; affected devices should be checked for the missing tube-spacer and warning label.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0230-2024 — Philips Philips Hello, I own a Philips that is covered by recall Z-0230-2024 from Philips. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
