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Ingenia recallZ-1567-2024 · Philips North America Llc · initiated Mar 12, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips North America Llc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Patient support table floor plate may be incorrectly installed.

FDA root cause category: Process design

What the company is doing

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 [email protected].

Recall details

Recall number
Z-1567-2024
Status
Open, Classified
Initiated by the company
Mar 12, 2024
Posted by the FDA
Apr 17, 2024
Recalling firm
Philips North America Llc
Quantity
342 units
Product code
LNH
FDA submissions
K193215
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.

Product description

Ingenia 3.0T CX, Magnetic Resonance System.

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

Model No. 781271, 782105; UDI-DI 884838068452, 884838098312; Serial No. 78000, 78003, 78004, 78005, 78007, 78035, 78062, 78010, 78009, 78011, 78012, 78014, 78013, 78015, 78016, 78017, 78018, 78025, 78021, 78019, 78023, 78043, 78068, 78026, 78053, 78027, 78028, 78039, 78029, 78030, 78031, 78032, 78033, 78034, 78036, 78038, 78040, 78070, 78042, 78044, 78045, 78082, 78046, 78047, 78048, 78049, 78051, 78115, 78050, 78008, 78058, 78059, 78060, 78063, 78064, 78065, 78067, 78066, 78071, 78072, 78073, 78074, 78075, 78076, 78077, 78078, 78080, 78081, 78083, 78084, 78086, 78087, 78088, 78089, 78091, 78092, 78094, 78095, 78101, 78096, 78097, 78099, 78098, 78100, 78102, 78113, 78114, 78109, 78103, 78104, 78106, 78107, 78110, 78117, 78112, 78118, 78111, 78120, 78129, 78121, 78122, 78123, 78126, 78127, 78128, 78132, 78133, 78135, 78138, 78137, 78139, 78140, 78141, 78142, 78145, 78149, 78147, 78148, 78150, 78151, 78154, 78155, 78156, 78158, 78162, 78164, 78166, 78167, 78157, 78171, 78173, 78172, 78175, 78161, 78170, 78180, 78182, 78183, 78186, 78187, 78188, 78223, 78189, 78190, 78193, 78194, 78195, 78196, 78197, 78198, 78199, 78201, 78202, 78022, 78203, 78206, 78181, 78207, 78208, 78209, 78210, 78205, 78213, 78212, 78214, 78215, 78221, 78216, 78217, 78218, 78240, 78219, 78222, 78224, 78227, 78229, 78225, 78232, 78233, 78234, 78235, 78239, 78242, 78243, 78241, 78244, 78247, 78249, 78250, 78251, 78252, 78254, 78253, 78255, 78256, 78259, 78263, 78260, 78261, 78262, 78266, 78264, 78265, 78238, 78267, 78268, 78273, 78269, 78270, 78271, 78272, 78280, 78281, 78277, 78279, 78283, 78282, 78284, 78286, 78287, 78288, 78289, 78290, 78293, 78294, 78291, 78292, 78257, 78295, 78297, 78296, 78298, 78299, 78301, 78305, 78306, 78307, 78308, 78309, 78310, 78312, 78313, 78316, 78317, 78314, 78319, 78320, 78321, 78322, 78323, 78324, 78326, 78328, 78327, 78329, 78330, 78332, 78333, 78334, 78335, 78336, 78339, 78340, 78337, 78338, 78341, 78342, 78345, 78346, 78347, 78352, 78353, 78354, 78356, 78357, 78358, 78501, 78364, 78359, 78363, 78361, 78360, 78362, 78366, 78503, 78500, 78504, 78368, 78508, 78505, 78513, 78512, 78507, 78370, 78377, 78374, 78375, 78376, 78386, 78516, 78517, 78518, 78519, 78524, 78522, 78523, 78521, 78525, 78526, 78527, 78531, 78529, 78530, 78532, 78533, 78535, 78536, 78537, 78538, 78539, 78540, 78543, 78542, 78544, 78545, 78546, 78547, 78548, 78549, 78550, 78553, 78554, 78560, 78561, 78557, 78556, 78559, 78562, 78564, 78565, 78566, 78567.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 94233).

Sources and updates

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