Home / Recalls / Philips North America Llc / Z-1577-2024

Z-1577-2024 Class II Ongoing

Recalled by Philips North America Llc — Cambridge, MA

FDA device recall Z-1577-2024 was initiated by Philips North America Llc on Mar 12, 2024 and is designated Class II. Reason for recall: Patient support table floor plate may be incorrectly installed. The recall status is ongoing. Affected quantity: 46 units.

Recall Details

Product Type: Devices
Report Date: Apr 24, 2024
Initiation Date: Mar 12, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 46 units

Product Description

Intera 1.5T Achieva Nova, Magnetic Resonance System.

Reason for Recall

Patient support table floor plate may be incorrectly installed.

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.

Code Information

Model No. 781172; UDI-DI n/a; Serial No. 12144, 12075, 12031, 12015, 12056, 12051, 12107, 12078, 12065, 12045, 12046, 12026, 12105, 12062, 12111, 12077, 12044, 12049, 12119, 12081, 12161, 12099, 12138, 12020, 12139, 12102, 12069, 12152, 12004, 12086, 12122, 12128, 12052, 12063, 12005, 12050, 12141, 12025, 12106, 12146, 12001, 11010, 12074, 12073, 12079, 12057.

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1577-2024
openFDA file date: Oct 26, 2026
Loaded by RegDataLab: Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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