Z-1071-2026Class II

Allura Xper FD20 Biplane; Model Number: 722013

Name: Z-1071-2026 Allura Xper FD20 Biplane; Model Number: 722013
Creator: Philips Medical Systems Nederland B.v.
Published: 2025-12-15
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2025-12-15 / Open, Classified / root cause: packaging

FDA source

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of Allura Xper FD20 Biplane; Model Number: 722013 on 2025-12-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1071-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-15
Posted: 2026-01-13
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Allura Xper FD20 Biplane; Model Number: 722013;
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
Root cause tag: packaging
FDA root cause: Other
Action: 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.
Quantity in commerce: 23 units
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 codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1071-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1062-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-13
Z-1063-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-13
Z-1064-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-13
Z-1065-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-13
Z-1066-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-13
Z-1067-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-13
Z-1068-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-13
Z-1069-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-13
Z-1070-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-13
Z-1071-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-13
Z-1072-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-13
Z-1073-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-13
Z-1074-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-13
Z-1075-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-13
Z-1076-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-13
Z-1077-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-13

Product code OWB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)