PlainRecalls
FDA Devices Moderate Class II Ongoing

Intera 1.5T R11, Magnetic Resonance System.

Reported: April 24, 2024 Initiated: March 12, 2024 #Z-1583-2024

Product Description

Intera 1.5T R11, Magnetic Resonance System.

Reason for Recall

Patient support table floor plate may be incorrectly installed.

Details

Recalling Firm
Philips North America Llc
Units Affected
25 units
Distribution
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, T'rkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe.
Location
Cambridge, MA

Frequently Asked Questions

What product was recalled?
Intera 1.5T R11, Magnetic Resonance System.. Recalled by Philips North America Llc. Units affected: 25 units.
Why was this product recalled?
Patient support table floor plate may be incorrectly installed.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 24, 2024. Severity: Moderate. Recall number: Z-1583-2024.