PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Medical Device Recall in 2026 - (Recall #: Z-1071-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

Allura Xper FD20 Biplane; Model Number: 722013;

Product Classification:

Class II

Date Initiated: December 15, 2025

Date Posted: January 21, 2026

Recall Number: Z-1071-2026

Event ID: 98109

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 23 units

Code Information:

Model Number: 722013; System Product Name: Allura Xper FD20 Biplane; UDI-DI: 00884838059061; Serial Numbers: 601, 230, 370, 27, 320, 193, 60, 373, 560, 400, 549, 506, 381, 382, 132, 169, 233, 236, 243, 526, 447, 163, 403;

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated