CLASS I ONGOING Device recall · Reported 26 Feb 2025 · FDA Enforcement Report
Cardio Vascular-Allura Centron recalled by Philips Medical Systems
Philips Medical Systems Nederl is recalling Cardio Vascular-Allura Centron, distributed nationwide in the US. The recall was initiated on 13 Jan 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1161-2025
- FDA event ID
- 96132
- Recalling firm
- Philips Medical Systems Nederl, Best, N/A
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 13 Jan 2025
- FDA classified
- 20 Feb 2025
- Reported
- 26 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 13 Jan 2025 | Recall initiated by company | |
| 20 Feb 2025 | Classified by FDA | +38 days |
| 26 Feb 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Possibility of the patient falling from the table related to the mattress used on the patient table.
Product as listed by the FDA
Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY).
Where it was distributed
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.
Questions about this recall
Why was it recalled?
Possibility of the patient falling from the table related to the mattress used on the patient table.
Which lots are affected?
Catalog numbers: (1) 722400; UDI-DI: No UDI; Serial Numbers: 531, 314, 432, 376, 496, 315, 491, 361, 389, 486, 427, 547, 330, 444, 441, 536, 479, 555, 443, 329, 440, 363, 445, 344, 286, 508, 446, 511, 135, 291, 221, 31, 143, 79, 69, 2, 160, 381, 157, 386, 174, 269, 206, 240, 151, 348, 283, 308, 188, 370, 477, 360, 319, 482, 317, 6, 199, 217, 218, 76, 364, 382, 233, 16, 258, 271, 393, 407, 184, 303, 338, 414, 321, 89, 413, 429, 502, 506, 507, 33.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
19 other products · FDA event 96132This product is part of a recall event; the main page for the event is Allura Xper Biplane recalled by Philips Medical Systems.
More recalls from Philips Medical Systems Nederl
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|---|---|---|---|---|---|
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederl | Potency & Assay | |
| Device | CLASS II | Allura Xper FD recalled by Philips Medical Systems | Philips Medical Systems Nederl | Other | Nationwide |
| Device | CLASS II | Philips Allura, Cardio Vascular-Allura Centron recalled | Philips Medical Systems Nederl | Other | Nationwide |
| Device | CLASS II | Philips Allura Xper with the following recalled | Philips Medical Systems Nederl | Other | |
| Device | CLASS II | Philips MultiDiagnost Eleva with the following recalled | Philips Medical Systems Nederl | Other |
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