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.
- Transfer of patient
- Instructions for the use of the Mattress
- 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
- FDA’s Enforcement Report Entries:
- Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026
- Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027
- Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028
- Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013
- Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025
- Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035
- Allura Xper FD20/10; Catalog numbers: 722029
- Allura Xper FD20/15; Catalog numbers: 722058
- Allura Xper FD20/20; Catalog numbers: 722038
- Allura CV20; Catalog numbers: 722031
- Allura Xper FD10C; Catalog number: 722001
- Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY)
- Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221
- Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY)
- Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY)
- Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY)
- Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY)
- Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236
- Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY)
- Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY)
- Medical Device Recall Database Entries:
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 recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
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.
