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  5. Patient Table Correction: Philips Updates Use Instructions for Allura and Azurion Systems due to Patient Fall Risk from Incorrectly Positioned Mattresses
  1. Medical Device Recalls

Patient Table Correction: Philips Updates Use Instructions for Allura and Azurion Systems due to Patient Fall Risk from Incorrectly Positioned Mattresses

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  

Incorrect positioning of mattresses
  • 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.
Example of mattress movement during patient movement or repositioning that could lead to patient falling.
  • Use of correct mattress and positioning of the mattress on the tabletop
    • Ensure that the appropriate mattress is used on the table.
Types of mattresses and their positioning on the table.
  • Be aware that the mattress is placed on the tabletop with the table surface completely supporting the mattress.
Correct positioning of the mattress on the table.
  • Please be aware of the narrow area of the neuro tabletop. Do not place the mattress where the tabletop is not underneath the mattress.
Incorrect positioning of the neuro and cardiac mattress on the table.
  • 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 CodeUDI
Allura CV20722031-
Allura Xper FD1072200300884838059191(10)
 72201000884838059030(21)
 722026 00884838054189(21)
 AlluraXper FD10/1072200500884838059191(10)
00884838080805(10)
 722011-
 72202700884838054196(21)
Allura Xper FD10C722001-
AlluraXper FD20722006 00884838055513(21)
00884838059115(21)
00884838059191(10)
 72201200884838059054(21)
 72202800884838054202(21)
AlluraXper FD20 Biplane72200800884838059191(10)
 72201300884838059061(21)
AlluraXper FD20 Biplane OR Table722020-
 722025-
AlluraXper FD20 OR Table722023-
 722035-
AlluraXperFD20/1072202900884838054219(21)
Allura Xper FD20/20722038 00884838054226(21)
ALluraXperFD20/15 72205800884838059115(21)
Azurion 3 M1272206300884838085275(21)
Azurion 3 M1572222100884838099203(21)
 72206400884838085282(21)
 72222200884838099210(21)
 72228000884838103276(21)
Azurion 5 M1272222700884838099227(21)
 72223100884838116740(21)
Azurion 5 M20722228 00884838099234(21)
 72223200884838116757(21)
 72228100884838110564(21)
Azurion 7 B1272206700884838085350(21)
 72222500884838099265(21)
 72223500884838116788(21)
Azurion 7 B2072206800884838085367(21)
 72222600884838099272(21)
 72223600884838116801(21)
Azurion 7 M1272207800884838085251(21)
 72222300884838099241(21)
 72223300884838116764(21)
Azurion 7 M20722224 00884838099258(21)
 72207900884838085268(21)
 72223400884838116771(21)
 72228200884838110571(21)
Cardiovascular-Allura Centron72240000884838042315(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. 

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