PlainRecalls
FDA Devices Critical Class I Ongoing

Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

Reported: February 26, 2025 Initiated: January 13, 2025 #Z-1160-2025

Product Description

Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

Reason for Recall

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

Details

Units Affected
4,221 units (1480 US, 2741 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?
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);. Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Units affected: 4,221 units (1480 US, 2741 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-1160-2025.