Allura Xper FD recallZ-1895-2024 · Philips Medical Systems Nederland B.V. · initiated May 16, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips Medical Systems Nederland B.V. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.
FDA root cause category: Under Investigation by firm
What the company is doing
On May 14, 2024 URGENT Medical Device Correction letters were sent to consignees. Actions that should be taken by the customer / user to lower risks for patients: " Circulate this Urgent Medical Device Correction letter to all users so that they are aware of the issue. " Philips recommends discontinuing use of the system for procedures that can be safely postponed to another time, or for procedures that can be performed with another system. " Keep this Urgent Medical Device Correction letter with the documentation of the system until Philips corrects your system. Ensure the letter is in a place likely to be seen/viewed. " Please complete and return the attached response form (on page 3) to Philips promptly and no later than 15 days from receipt. Completing this form confirms receipt of the Medical Device Correction letter and understanding of the issue and required actions to be taken. 5. Actions planned by Philips IGT-S to correct the issue: Philips will be re-installing the previous software release in all affected systems. Philips will contact affected customers immediately to schedule a visit to perform this software change (reference FCO72200588). If you need additional information or support concerning this issue, please contact your local Philips representative at 1-800-722-9377 (Philips Customer Care Solutions Center).
Recall details
- Recall number
- Z-1895-2024
- Status
- Open, Classified
- Initiated by the company
- May 16, 2024
- Posted by the FDA
- May 24, 2024
- Recalling firm
- Philips Medical Systems Nederland B.V.
- Quantity
- 1 unit (US)
- Product code
- OWB
- FDA submissions
- K162859
- Distribution
- Domestic: OK International: India, Spain, U.A.E.
Product description
Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.
Code information (models, lots, serial numbers)
Product number: 722012, UDI/DI: 00884838059054; Serial Number: 2138.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Allura Xper FD Allura Xper FD20Philips Medical Systems Nederland B.V. · Interventional Fluoroscopic X-Ray System23 recalls2 deaths3,614 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 94647).
- Z-1896-2024 · Open, ClassifiedPhilips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.
- Z-1897-2024 · Open, ClassifiedPhilips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1.100.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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