Philips Allura and Azurion Patient Table Recall

Medical device recalls are always concerning, especially when they involve equipment used in critical healthcare settings like operating rooms. Recently, Philips issued an urgent update to the use instructions for its Allura and Azurion systems due to a serious risk of patient falls from incorrectly positioned mattresses. This recall does not remove the devices from use but instead provides additional guidance to prevent potential injuries.

Why Are Philips Allura and Azurion Systems Being Updated?

Philips has identified that in some situations, patients may fall from the operating table due to mattress slippage, incorrect mattress positioning, or the use of an incompatible mattress. This issue is significant enough that the FDA has classified the recall as the most serious type, meaning continued improper use of the device may result in serious injury or death.

What Are the Risks?

Patients who fall from these operating tables could suffer severe injuries, including:

• Bruises (contusions)
• Bleeding under the skin (hematoma)
• Skin abrasions and scratches
• Stiffness and mobility issues
• Intracranial hemorrhage (bleeding in the skull)
• Large and complex cuts (lacerations)
• Death (though none have been reported so far)

So far, there have been five reported injuries associated with these devices. While no deaths have been recorded, the possibility of severe harm remains high if hospitals do not follow the updated safety instructions.

Affected Products

The recall applies to:

• Philips Allura and Azurion systems used with a Philips mattress
• Specific models and serial numbers listed by Philips

Healthcare providers who use these systems must ensure that mattresses are placed correctly and that patient transfer procedures follow the updated guidelines to prevent falls.

What Should Healthcare Facilities Do?

Philips issued an Urgent Medical Device Correction letter on January 13, 2025, outlining steps hospitals must take:

1. Distribute the updated instructions to all medical staff.
2. Follow new mattress positioning guidelines, which include:
   • Ensuring the mattress is completely supported by the tabletop.
   • Using the correct mattress for the specific table type.
   • Opening the air plug to allow proper mattress expansion and contraction.
3. Properly transfer patients, communicating with other staff to avoid mattress movement that could lead to a fall.
4. Download and follow the Instructions for Use addendum and Quick Reference Card available on Philips’ website.
5. Complete a response form within 30 days and report any issues to Philips at 1-800-722-9377.

The Dangers of Defective Medical Devices

This recall highlights the dangers of defective medical devices and why medical device litigation is crucial in holding manufacturers accountable. While Philips is addressing this issue with updated guidance, the fact remains that patients have already been injured due to design flaws and inadequate instructions.

Defective medical devices can lead to life-threatening consequences, including:

• Surgical complications
• Long-term disabilities
• Additional medical costs
• Wrongful death

Hospitals and medical professionals rely on manufacturers to provide safe and effective devices. When companies fail to do so, they must be held responsible.

Philips Azurion and Allura Systems: What You Should Know

The Philips Azurion operating system and Philips Allura systems are widely used in hospitals for patient imaging and surgical procedures. These systems are designed for precision and efficiency, but when a critical component like the mattress positioning mechanism fails, it puts patients at risk.

The Philips Azurion system features advanced imaging technology, but safety concerns regarding mattress positioning overshadow its benefits. Medical device attorneys are closely examining whether Philips adequately tested and warned about these issues before distributing the systems.

Legal Help for Patients Affected by Defective Medical Devices

If you or a loved one has been injured due to a defective medical device, including patient tables like the Philips Allura and Azurion systems, you may be entitled to legal compensation.

KBD Attorneys is actively investigating this recall and handles cases related to medical device litigation. Our experienced medical device attorneys have helped victims recover compensation for:

• Medical expenses
• Pain and suffering
• Lost wages due to extended recovery time
• Wrongful death claims (in cases of fatal injuries)

How a Defective Medical Device Attorney Can Help

If a medical device defect caused injury, you need an experienced defective medical device attorney who understands how to hold large manufacturers accountable. At KBD Attorneys, we specialize in cases involving faulty medical products and have successfully taken on major corporations in product liability lawsuits.

What to Do if You’ve Been Affected

If you or a loved one suffered injuries due to the Philips Allura or Azurion patient table recall, here’s what you should do:

1. Seek medical attention immediately for any injuries sustained.
2. Report the issue to your healthcare provider and ensure they follow the updated safety guidelines.
3. Document everything, including medical records, witness statements, and any communications with Philips.
4. Contact a medical device attorney to explore your legal options.

Final Thoughts

While Philips’ updated guidance aims to prevent further injuries, this recall serves as another reminder of the risks associated with defective medical devices. If you or a loved one has been affected, KBD Attorneys is here to help. Our team is actively investigating Philips Allura and Philips Azurion operating system cases and is committed to securing justice for those harmed by unsafe medical equipment.

For more information on how we can assist you, contact KBD Attorneys today to speak with a defective medical device attorney about your case.