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Allura Xper FD recallZ-1075-2026 · Philips Medical Systems Nederland B.V. · initiated Dec 15, 2025

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

FDA root cause category: Other

What the company is doing

On December 15, 2025, URGENT Medical Device Correction letters were sent to customers. Actions to be taken: a. Affected systems may continue to be used in accordance with their Instructions for Use (IFU). b. Circulate this letter to all users so that they are aware of the issue. Keep this letter with the documentation of the system until Philips inspects and, where needed, corrects your system. c. Establish an emergency protocol prior to all applicable diagnostics, interventional and minimally invasive procedures to manage the situation should you experience the issue during a procedure. d. If you detect a burning odor, smoke, or fire originating from the R-cabinet in the technical room, immediately switch off the system s main power. Do not operate or use the system further. Follow your institution s emergency procedures. e. In case the affected system has been transferred to another organization, please send a copy of this letter to that organization and inform Philips about this transfer through your local Philips representative. f. Complete and return the attached response form to Philips promptly and no later than 30 days from receipt. g. Should you experience the issue reported in this letter, please report the event to Philips through your local Philips representative.

Recall details

Recall number
Z-1075-2026
Status
Open, Classified
Initiated by the company
Dec 15, 2025
Posted by the FDA
Jan 13, 2026
Recalling firm
Philips Medical Systems Nederland B.V.
Quantity
2 units
Product code
OWB
FDA submissions
K102005, K130638, K130842, K133292, K161563, K141979
Distribution
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, India, Italy, Japan, Kenya, Korea, Republic of, Malaysia, Mexico, Nepal, Netherlands, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen.

Product description

Allura Xper FD20; Model Number: 722028;

Code information (models, lots, serial numbers)

Model Number: 722028; System Product Name: Allura Xper FD20; UDI-DI: 00884838054202; Serial Numbers: 893, 614;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 98109).

Sources and updates

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