FDA Devices Critical Class I Ongoing

Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.

Reported: February 26, 2025 Initiated: January 13, 2025 #Z-1145-2025

Product Description

Reason for Recall

Possibility of the patient falling from the table related to the mattress used on the patient table.

Details

Recalling Firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Units Affected: 479 units (186 US, 293 OUS)
Distribution: Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.
Location: Best, N/A

Frequently Asked Questions

What product was recalled? ▼

Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.. Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Units affected: 479 units (186 US, 293 OUS).

Why was this product recalled? ▼

Possibility of the patient falling from the table related to the mattress used on the patient table.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on February 26, 2025. Severity: Critical. Recall number: Z-1145-2025.