Correction: Philips Updates Instructions for Allura and Azurion System

This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.

Affected Product

Product Names: Philips Allura and Azurion systems used with a Philips mattress
Unique Device Identifier (UDI)/Model: See full list of affected devices below.
Lot/Serial Numbers: See full list of affected devices below.

What to Do

Follow additional instructions provided by Philips as an addendum to the instructions for use and as a Quick Reference Card.

On January 13, 2025, Philips sent all affected customers an Urgent Medical Device Correction recommending the following actions:

Circulate the letter to all users so they are aware of the issue.
Follow additional instructions on the use of the mattress, which will be provided as an addendum to the Instructions for Use and a Quick Reference Card. The instructions were attached to the letter as Appendix B and include:
- Instructions for the use of the Mattress
  - Transfer of patient
    - Communicate clearly with the other hospital staff during the transfer process to ensure that everyone is aware of the patient’s weight and position.
    - Open the air plug of the mattress. Opening the air plug allows the mattress to expand and contract with the weight of the patient.
    - Ensure that patient transfer devices are used correctly.
    - Move the patient carefully and avoid movements that could cause the mattress to slip.
    - If a patient positions themselves on the table, ensure that the patient knows that the mattress is NOT fixed to the table.

Use of correct mattress and positioning of the mattress on the tabletop
- Ensure that the appropriate mattress is used on the table.

Be aware that the mattress is placed on the tabletop with the table surface completely supporting the mattress.

Please be aware of the narrow area of the neuro tabletop. Do not place the mattress where the tabletop is not underneath the mattress.

Download the Instructions for Use addendum and Quick Reference Card in multiple languages at: https://www.usa.philips.com/healthcare/about/support/resource-center
Send a copy of the letter to any organization that may have received these devices and report this information to Philips by email at IGT_Recalls@philips.com.
Complete the response form attached to the letter within 30 days of receiving it.
Report any of these issues if they occur to the local Philips representative at 1-800-722-9377.

Reason for Updates to Use Instructions

Philps is updating use instructions for Allura and Azurion system patient tables after identifying some situations that may result in the patient falling from the table. These situations include: the mattress slipping from the table during patient transfer, incorrect positioning of the neuro mattress on the table, or if the incorrect mattress is being used on the table.

The use of affected product may cause serious adverse health consequences, including bruises (contusions), bleeding under the skin outside of blood vessels (hematoma), scratches, skin abrasions, stiffness, bleeding in the skull (intracranial hemorrhage), large and/or complex cuts (lacerations), and death.

There have been five reported injuries. There have been no reports of death.

Device Use

Philips Allura and Azurion systems are types of patient tables used in operating rooms.

Contact Information

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

Full List of Affected Devices

Commercial Name	System Code	UDI
Allura CV20	722031	–
Allura Xper FD10	722003	00884838059191(10)
	722010	00884838059030(21)
	722026	00884838054189(21)
AlluraXper FD10/10	722005	00884838059191(10) 00884838080805(10)
	722011	–
	722027	00884838054196(21)
Allura Xper FD10C	722001	–
AlluraXper FD20	722006	00884838055513(21) 00884838059115(21) 00884838059191(10)
	722012	00884838059054(21)
	722028	00884838054202(21)
AlluraXper FD20 Biplane	722008	00884838059191(10)
	722013	00884838059061(21)
AlluraXper FD20 Biplane OR Table	722020	–
	722025	–
AlluraXper FD20 OR Table	722023	–
	722035	–
AlluraXperFD20/10	722029	00884838054219(21)
Allura Xper FD20/20	722038	00884838054226(21)
ALluraXperFD20/15	722058	00884838059115(21)
Azurion 3 M12	722063	00884838085275(21)
Azurion 3 M15	722221	00884838099203(21)
	722064	00884838085282(21)
	722222	00884838099210(21)
	722280	00884838103276(21)
Azurion 5 M12	722227	00884838099227(21)
	722231	00884838116740(21)
Azurion 5 M20	722228	00884838099234(21)
	722232	00884838116757(21)
	722281	00884838110564(21)
Azurion 7 B12	722067	00884838085350(21)
	722225	00884838099265(21)
	722235	00884838116788(21)
Azurion 7 B20	722068	00884838085367(21)
	722226	00884838099272(21)
	722236	00884838116801(21)
Azurion 7 M12	722078	00884838085251(21)
	722223	00884838099241(21)
	722233	00884838116764(21)
Azurion 7 M20	722224	00884838099258(21)
	722079	00884838085268(21)
	722234	00884838116771(21)
	722282	00884838110571(21)
Cardiovascular-Allura Centron	722400	00884838042315(21)

Additional FDA Resources

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.