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Recall Observatory FDA recall evidence

Device product

MR 7700, Magnetic Resonance System.

Z-1588-2024

March 12, 2024

Class II

Product summary

Firm
Philips North America Llc
Event
Event 94233
Status
Ongoing
Classification
Class II
Quantity
26 units
Official record key
device-enforcement:Z-1588-2024

Official wording

Reason: Patient support table floor plate may be incorrectly installed.

Code information: Model No. 782120; UDI-DI 884838104112; Serial No. 65051, 65005, 65000, 65002, 65003, 65001, 65004, 65009, 65012, 65013, 65015, 65017, 65020, 65019, 65021, 65023, 65024, 65025, 65031, 65006, 65032, 65035, 65034, 65038, 65030, 65037.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Patient support table floor plate may be incorrectly installed.