Recalls / —

—#206729

Product

Intera 1.5T R11, Magnetic Resonance System.

FDA product code

LNH — System, Nuclear Magnetic Resonance Imaging

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K193215

Affected lot / code info

Model No. 781170; UDI-DI n/a; Serial No. 18070, 18021, 18025, 18110, 18019, 18009, 18055, 18064, 18095, 18105, 18002, 18082, 18083, 18039, 18108, 18032, 18071, 18092, 18074, 18030, 18011, 18049, 18066, 18097, 18031.

Why it was recalled

Patient support table floor plate may be incorrectly installed.

Root cause (FDA determination)

Process design

Action the firm took

Consignees were mailed an URGENT Medical Device Correction notice, dated 3/12/24. Consignees are instructed by the notice to identify affected systems, which can continue to be used with the provided instruction. If a patient's weight is at or near the maximum load of the device take care that they do not sit on the end of the tabletop opposite the bore entrance and that they do not hop down from their sitting position while the support is at its highest position. If the affected system has any unexpected movement or becomes unstable immediately stop use and contact your Philips representative for interim support. The recall notice is to be circulated to all users and the provided advisory displayed. Completed response forms are to be emailed to pd.cnr@philips.com.

Recalling firm

Firm

Philips North America Llc

Address

222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

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.

Timeline

Recall initiated

2024-03-12

Posted by FDA

2024-04-17

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #206729. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.