Philips X-Ray Table Recall Issued After Injuries Reported

Manufacturer has issued additional instructions for using the Allura and Azurion systems following multiple reports of x-ray table injuries.

Federal health officials are alerting healthcare providers about an issue concerning Philips Allura and Azurion x-ray table systems, after identifying situations where problems with the tables could cause patients to fall and sustain serious injuries.

The Philips Allura and Azurion systems are patient tables outfitted with x-ray imaging equipment. They are commonly used in operating rooms to provide real-time visualization during minimally invasive procedures, helping doctors precisely place catheters and other medical devices.

However, the U.S. Food and Drug Administration (FDA) announced a Philips Allura and Azurion x-ray table warning on February 28, after receiving multiple reports of patient injuries caused by issues with mattress positioning and stability, which the agency warns can lead to potentially life-threatening injuries.

According to the recall, officials warn that patients may be at risk of falls and injuries due to mattresses slipping during transfers, improper positioning on the table, or the use of incorrect mattresses. These issues can lead to serious harm, including bruises, hematomas, skin abrasions, stiffness, hemorrhage, lacerations or even death.

Philips has reported five injuries related to this issue, prompting the FDA to classify the recall as its most serious type.

The recall includes the following operating room table systems: Allura CV20, Allura Xper FD10, Allura Xper FD10/10, Allura Xper FD10C, Allura Xper FD20, Allura Xper FD20 Biplane, Allura Xper FD20 Biplane OR Table, Allura Xper FD20 OR Table, Allura Xper FD20/10, Allura Xper FD20/20, Allura Xper FD20/15, Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20, Cardiovascular-Allura Centron.

A complete list of affected Unique Device Identifiers (UDI), models, and lot/serial numbers for both the Allura system and the Azurion system is available on the FDA’s website.

On January 13, Philips issued an Urgent Medical Device Correction letter to healthcare providers, advising them to follow updated mattress-use instructions and share the information with other users. The new guidelines emphasize:

• Safe patient transfers: Staff should communicate clearly about the patient’s weight and position.
• Proper mattress use: Ensure the correct mattress is fully supported by the table and that patients are carefully positioned to prevent slippage.
• Air plug adjustment: Open the mattress air plug to allow for proper expansion and contraction with the patient’s weight.
• Patient awareness: If a patient moves themselves onto the table, they should be informed that the mattress is not fixed.

Philips is requesting that the response forms attached to letters be returned within 30 days of receipt and that any issues be reported to the customer’s local Philips representative at 1-800-722-9377.

Customers in the U.S. with questions about this recall can also contact their local Philips representative at Philips Customer Care Solutions at 1-800-722-9377.