FDA Medical devices recall ·
Allura Xper FD20 Biplane recall
- Recall number
- Z-1067-2026
- Date
- (initiated December 15, 2025)
- Company / brand
- Philips Medical Systems Nederland B.V.
Veenpluis 4-6, Best, Netherlands - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 18 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Allura Xper FD20 Biplane; Model Number: 722008;
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: 722008; System Product Name: Allura Xper FD20 Biplane; UDI-DI: N/A; Serial Numbers: 296, 245, 141, 260, 13, 410, 196, 476, 488, 290, 339, 474, 383, 530, 722008530, 223, 468, 63;
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1067-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.