Recalls / —

—#212096

Product

Allura Xper FD20/10; Catalog numbers: 722029

FDA product code

OWB — Interventional Fluoroscopic X-Ray System

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K033737, K162859

Affected lot / code info

Catalog number: 722029; UDI-DI: 00884838054219; Serial Numbers: 71, 91, 7, 94, 62, 88, 36, 97, 21, 100, 30, 63, 60, 129, 84, 95, 126, 110, 56, 55, 57, 31, 119, 87, 93, 24, 32, 39, 34, 14, 122, 127, 45, 48, 37, 23, 44, 40, 66, 38, 98, 75, 35, 89, 82, 61, 53, 25, 58, 33, 85, 27, 46, 19, 29, 20, 92, 52, 104, 70, 65, 109, 78, 96, 26, 59, 118, 108, 49, 50, 51, 128, 107, 114, 124, 103, 106, 81, 80, 47, 123, 116, 101, 79, 120, 43, 102.

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On January 14, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. 4. Actions that should be taken by the customer / user in order to prevent risks for patients or users " Circulate this Urgent Medical Device Correction letter to all users of the system so that they are aware of the issue. " Follow the additional instructions on the use of the mattress included in Appendix B. These instructions include information for the transfer of the patient and the correct use and positioning of the mattress. The information of this Appendix is being included in an Addendum to the Instructions for Use. Additionally, Philips is creating a Quick Reference Card. The Addendum and the Quick Reference Card will be available as from end of March 2025. Please refer to Appendix C on how to download the Addendum to the Instructions for Use and the Quick Reference Card. " In case that the affected system has been transferred to another organization, please send a copy of this Urgent Medical Device Correction letter to that organization and inform Philips about this transfer through the email account: IGT_Recalls@philips.com " Please complete and return the Response form attached to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction letter and understanding of the issue and required actions to be taken. " Should you experience the issue reported in this letter, please report the event to Philips through your local Philips representative (1- 800-722-9377). 5. Actions planned by Philips Image Guided Therapy Systems to correct the problem Philips is informing customers of this issue through this Urgent Medical Device Correction. Additionally, Philips is releasing an Addendum to the Instructions for Use and a Quick Reference Card that will be available for customers at the end of March 2025. This Urgent Medical Device Correction letter has been reported to the appropriate Regulatory Agencies.

Recalling firm

Firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2025-01-13

Posted by FDA

2025-02-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #212096. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.