Philips recalls BV Endura and Pulsera mobile surgery C-arm systems sold in Puerto Rico due to missing warning labels and Source-to-Skin Distance Spacer. Affected units may not be safe for medical use.
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 specific mobile surgery C-arm systems sold in Puerto Rico because they lack warning labels and have a missing Source-to-Skin Distance Spacer. This could lead to unsafe medical procedures if the equipment is used without proper safety features.
The missing Source-to-Skin Distance Spacer and warning label could cause improper positioning of the surgical equipment, potentially leading to unsafe medical procedures. Without these safety features, the systems might not function correctly during surgery.
Healthcare providers in Puerto Rico who own or use the recalled Philips BV Endura or Pulsera mobile surgery C-arm systems are most at risk. These systems are used for image-guided therapy during surgeries.
Check if your Philips BV Endura or Pulsera mobile surgery C-arm system has a model number listed in the provided descriptions (e.g., Endura 2.2 1195, Pulsera 2.2 1623). These units were delivered to Puerto Rico without the required warning label and spacer.
Verify if your system has the required warning label as specified in the recall notice.
Ensure the Source-to-Skin Distance Spacer is included with your system before use.
Philips has identified that some BV Endura and Pulsera mobile surgery C-arm systems delivered to Puerto Rico lack the required warning label and Source-to-Skin Distance Spacer.
The affected models include Endura 2.2 1195, Endura 2.2 1202, Endura 2/3 95, and other specific model numbers listed in the recall notice.
The recall does not specify a stop-use instruction; affected units should be checked for the missing spacer and label before use.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0224-2024 — Philips Philips Hello, I own a Philips that is covered by recall Z-0224-2024 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.
