Allura Xper FD20/20; Catalog numbers: 722038
Enforcement
- Recall Number
- Z-1150-2025
- Event ID
- 96132
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 26, 2025
- Initiation Date
- January 13, 2025
- Classification Date
- February 20, 2025
- Address
- Veenpluis 4-6, N/A, Best, N/A, N/A, Netherlands
Description
Allura Xper FD20/20; Catalog numbers: 722038
Possibility of the patient falling from the table related to the mattress used on the patient table.
Catalog number: 722038; UDI-DI: 00884838054226; Serial Numbers: 39, 63, 42, 55, 67, 99, 60, 71, 141, 115, 7, 78, 108, 106, 167, 118, 130, 49, 119, 126, 173, 37, 38, 48, 62, 35, 137, 120, 41, 157, 96, 70, 46, 102, 153, 155, 171, 172, 163, 129, 161, 122, 156, 121, 168, 113, 169, 160, 152, 162, 164, 148, 159, 144, 111, 138, 158, 124, 140, 154, 147, 14, 166, 127, 94, 95, 90, 91, 93, 143, 92, 89, 150, 88, 34, 136, 66, 30, 58, 29, 54, 170, 28, 47, 36, 79, 98, 31, 146, 3, 123, 32, 5, 9, 27, 105, 69, 40, 75, 11, 104, 112, 50, 116, 73, 133, 110, 72, 117, 134, 135, 68, 64, 45, 109.
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.
114 units (33 US, 81 OUS)