Philips North America Llc Recall 94233
Description: Intera 1.5T Omni/Stellar, Magnetic Resonance System.
Philips North America Llc Recall 94233 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1581-2024 |
| Event ID | 94233 |
| Event Description | Intera 1.5T Omni/Stellar, Magnetic Resonance System. |
| Product Type | Devices |
| 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. |
| Quantity | 22 units |
| Recall Reason | Patient support table floor plate may be incorrectly installed. |
| Device Classification | 20240424 |
| Device Code Info | Model No. 781104; UDI-DI n/a; Serial No. 8483, 8526, 8257, 8171, 8731, 8126, 10403, 10401, 10410, 10407, 8266, 8286, 8246, 8725, 8556, 8338, 8625, 8516, 8332, 8138, 8921, 8359. |
| Center Classification Date | 20240417 |
| Recall Initiation Date | 20240312 |
| Recalling Firm | Philips North America Llc |
| Initial Notification | Letter |
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