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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93361

7 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 23, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Philips North America Llc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

7 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 7

Achieva 1.5T

Z-0389-2024
Recall number
Z-0389-2024
Initiated
October 23, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
520 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential component failure in the Gradient Coil could product smoke and/or fire.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential component failure in the Gradient Coil could product smoke and/or fire.

Code information

Product No. 781178, 781196, 781296, & 781343; UDI-DI: (01)00884838004108(21)8524, (01)00884838004108(21)32039, (01)00884838004108(21)32052, (01)00884838004108(21)32083, (01)00884838004108(21)32087, (01)00884838004108(21)32097, (01)00884838004108(21)32103, (01)00884838004108(21)32118, (01)00884838004108(21)32123, (01)00884838004108(21)32150, (01)00884838004108(21)32153, (01)00884838004108(21)32154, (01)00884838004108(21)32186, (01)00884838004108(21)32223, (01)00884838004108(21)32226, (01)00884838004108(21)32228, (01)00884838004108(21)32230, (01)00884838004108(21)32231, (01)00884838004108(21)32243, (01)00884838004108(21)32247, (01)00884838004108(21)32255, (01)00884838004108(21)32265, (01)00884838004108(21)32288, (01)00884838004108(21)32289, (01)00884838004108(21)32306, (01)00884838004108(21)32350, (01)00884838004108(21)32375, (01)00884838004108(21)32376, (01)00884838004108(21)32385, (01)00884838004108(21)32387, (01)00884838004108(21)32390, (01)00884838004108(21)32392, (01)00884838004108(21)32413, (01)00884838004108(21)32435, (01)00884838004108(21)32439, (01)00884838004108(21)32452, (01)00884838004108(21)32459, (01)00884838004108(21)32463, (01)00884838004108(21)32474, (01)00884838004108(21)32505, (01)00884838004108(21)32531, (01)00884838004108(21)32533, (01)00884838004108(21)32537, (01)00884838004108(21)32567, (01)00884838004108(21)32584, (01)00884838004108(21)32591, (01)00884838004108(21)32595, (01)00884838004108(21)32603, (01)00884838004108(21)32608, (01)00884838004108(21)32610, (01)00884838004108(21)32631, (01)00884838004108(21)32655, (01)00884838004108(21)32675, (01)00884838004108(21)32684, (01)00884838004108(21)32708, (01)00884838004108(21)32720, (01)00884838004108(21)32727, (01)00884838004108(21)32728, (01)00884838004108(21)32739, (01)00884838004108(21)32748, (01)00884838004108(21)32764, (01)00884838004108(21)32769, (01)00884838004108(21)32776, (01)00884838004108(21)32789, (01)00884838004108(21)32795, (01)00884838004108(21)32799, 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(01)00884838004108(21)32985, (01)00884838004108(21)32988, (01)00884838004108(21)32989, (01)00884838004108(21)32991, (01)00884838004108(21)32992, (01)00884838004108(21)32994, (01)00884838004108(21)32995, (01)00884838004108(21)32998, (01)00884838004108(21)33000, (01)00884838004108(21)33008, (01)00884838004108(21)33010, (01)00884838004108(21)33021, (01)00884838004108(21)33043, (01)00884838004108(21)33051, (01)00884838004108(21)33055, (01)00884838004108(21)33058, (01)00884838004108(21)33060, (01)00884838004108(21)33064, (01)00884838004108(21)33066, (01)00884838004108(21)33067, (01)00884838004108(21)33068, (01)00884838004108(21)33070, (01)00884838004108(21)33071, (01)00884838004108(21)33073, (01)00884838004108(21)33074, (01)00884838004108(21)33082, (01)00884838004108(21)33083, (01)00884838004108(21)33087, (01)00884838004108(21)33088, (01)00884838004108(21)33091, (01)00884838004108(21)33093, (01)00884838004108(21)33097, (01)00884838004108(21)33099, (01)00884838004108(21)33101, (01)00884838004108(21)33103, (01)00884838004108(21)33109, (01)00884838004108(21)33115, (01)00884838004108(21)33117, (01)00884838004108(21)33119, (01)00884838004108(21)33126, (01)00884838004108(21)33128, (01)00884838004108(21)33132, (01)00884838004108(21)33133, (01)00884838004108(21)33136, (01)00884838004108(21)33138, (01)00884838004108(21)33144, (01)00884838004108(21)33148, (01)00884838004108(21)33149, (01)00884838004108(21)33150, (01)00884838004108(21)33156, (01)00884838004108(21)33158, (01)00884838004108(21)33162, (01)00884838004108(21)33163, (01)00884838004108(21)33170, (01)00884838004108(21)33173, (01)00884838004108(21)33177, (01)00884838004108(21)33178, (01)00884838004108(21)33180, (01)00884838004108(21)33182, (01)00884838004108(21)33183, (01)00884838004108(21)33185, (01)00884838004108(21)33186, (01)00884838004108(21)33187, (01)00884838004108(21)33189, (01)00884838004108(21)33190, (01)00884838004108(21)33198, (01)00884838004108(21)33202, (01)00884838004108(21)33205, 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(01)00884838004108(21)33330, (01)00884838004108(21)33334, (01)00884838004108(21)33335, (01)00884838004108(21)33338, (01)00884838004108(21)33340, (01)00884838004108(21)33347, (01)00884838004108(21)33348, (01)00884838004108(21)33364, (01)00884838004108(21)33367, (01)00884838004108(21)33368, (01)00884838004108(21)33369, (01)00884838004108(21)33371, (01)00884838004108(21)33377, (01)00884838004108(21)33382, (01)00884838004108(21)33388, (01)00884838004108(21)33392, (01)00884838004108(21)33393, (01)00884838004108(21)33394, (01)00884838004108(21)33396, (01)00884838004108(21)33398, (01)00884838004108(21)33399, (01)00884838004108(21)33402, (01)00884838004108(21)33404, (01)00884838004108(21)33408, (01)00884838004108(21)33413, (01)00884838004108(21)33423, (01)00884838004108(21)33435, (01)00884838004108(21)33438, (01)00884838004108(21)33449, (01)00884838004108(21)33451, (01)00884838004108(21)33453, (01)00884838004108(21)33459, (01)00884838004108(21)33463, (01)00884838004108(21)33470, (01)00884838004108(21)33471, (01)00884838004108(21)33474, (01)00884838004108(21)33477, (01)00884838004108(21)33478, (01)00884838004108(21)33489, (01)00884838004108(21)33493, (01)00884838004108(21)33497, (01)00884838004108(21)33516, (01)00884838004108(21)33518, (01)00884838004108(21)33523, (01)00884838004108(21)33525, (01)00884838004108(21)33526, (01)00884838004108(21)33527, (01)00884838004108(21)33534, (01)00884838004108(21)33541, (01)00884838004108(21)33543, (01)00884838004108(21)33544, (01)00884838004108(21)33545, (01)00884838004108(21)33547, (01)00884838004108(21)33548, (01)00884838004108(21)33550, (01)00884838004108(21)33553, (01)00884838004108(21)33558, (01)00884838004108(21)33561, (01)00884838004108(21)33562, (01)00884838004108(21)33563, (01)00884838004108(21)33564, (01)00884838004108(21)33565, (01)00884838004108(21)33566, (01)00884838004108(21)33567, (01)00884838004108(21)33570, (01)00884838004108(21)33582, (01)00884838004108(21)33587, (01)00884838004108(21)33591, 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(01)00884838004108(21)33718, (01)00884838004108(21)33722, (01)00884838004108(21)33723, (01)00884838004108(21)33726, (01)00884838004108(21)33740, (01)00884838004108(21)33748, (01)00884838004108(21)33749, (01)00884838004108(21)33750, (01)00884838004108(21)33751, (01)00884838004108(21)33752, (01)00884838004108(21)33755, (01)00884838004108(21)33767, (01)00884838004108(21)33772, (01)00884838004108(21)33775, (01)00884838004108(21)33777, (01)00884838004108(21)33784, (01)00884838004108(21)33785, (01)00884838004108(21)33787, (01)00884838004108(21)33788, (01)00884838004108(21)33789, (01)00884838004108(21)33794, (01)00884838004108(21)33797, (01)00884838004108(21)33805, (01)00884838004108(21)33823, (01)00884838004108(21)33838, (01)00884838004108(21)33839, (01)00884838004108(21)33848, (01)00884838004108(21)33850, (01)00884838004108(21)33854, (01)00884838004108(21)33858, (01)00884838004108(21)33867, (01)00884838004108(21)33897, (01)00884838004108(21)33909, (01)00884838004108(21)36062, (01)00884838004108(21)39068, (01)00884838055292(21)72005, (01)00884838055292(21)72007, (01)00884838055292(21)72008, (01)00884838055292(21)72013, (01)00884838055292(21)72016, (01)00884838055292(21)72019, (01)00884838055292(21)72020, (01)00884838055292(21)72022, (01)00884838055292(21)72032, (01)00884838055292(21)72036, (01)00884838055292(21)72038, (01)00884838055292(21)72040, (01)00884838055292(21)72048, (01)00884838055292(21)72053, (01)00884838055292(21)72055, (01)00884838055292(21)72058, (01)00884838055292(21)72063, (01)00884838055292(21)72066, (01)00884838055292(21)72080, (01)00884838055292(21)72083, (01)00884838055292(21)72100, (01)00884838055292(21)72103, (01)00884838055292(21)72114, (01)00884838055292(21)72118, (01)00884838055292(21)72119, (01)00884838055292(21)72120, (01)00884838055292(21)72124, (01)00884838055292(21)72127, (01)00884838055292(21)72128, (01)00884838055292(21)72131, (01)00884838055292(21)72134, (01)00884838055292(21)72138, (01)00884838055292(21)72139, (01)00884838055292(21)72141, (01)00884838055292(21)72144, (01)00884838055292(21)72149, (01)00884838055292(21)72150, (01)00884838055292(21)72153, (01)00884838055292(21)72154, (01)00884838055292(21)72157, (01)00884838055292(21)72170, (01)00884838055292(21)72173, (01)00884838055292(21)72175, (01)00884838055292(21)72180, (01)00884838055292(21)72185, (01)00884838055292(21)72189, (01)00884838055292(21)72190, (01)00884838055292(21)72192, (01)00884838055292(21)72201, (01)00884838055292(21)72204, (01)00884838055292(21)72208, (01)00884838055292(21)72222, (01)00884838055292(21)72239, (01)00884838055292(21)72240, (01)00884838055292(21)72247, (01)00884838055292(21)72290, (01)00884838055292(21)72306, (01)00884838055292(21)72322; Serial No. 21034, 21035, 21082, 21083, 21133, 21158, 21165, 21178, 21184, 21205, 21209, 21212, 21225, 21237, 21240, 21242, 21246, 21247, 21249, 21262, 21265, 21269, 21271, 21292, 21299, 21320, 21327, 21333, 21343, 21345, 21359, 21369, 21396, 21397, 21428, 21431, 21438, 21448, 21458, 21480, 21503, 21530, 21540, 21552, 21556, 21577, 21580, 21607, 21647, 21677, 21682, 21684, 21686, 21688, 21690, 21704, 21706, 21711, 21713, 21724, 21725, 21848, 21851, 21876, 21879, 21895, 21900, 21913, 21914, 21935, 21961, 21988, 21994, 21995, 21996, 22019, 22026, 22051, 22052, 22053, 22055, 22065, 22078, 22080, 22085, 22103, 22117, 22119, 22133, 22135, 22147, 22152, 22158, 22165, 22175, 22176, 22179, 22193, 22201, 22210, 22224, 22233, 22234, 22246, 22251, 22254, 22257, 22259, 22262, 22273, 22281, 22313, 22316, 22318, 22323, 22326, 22328, 22330, 22361, 22379, 24184, 32086, 33022, 8524, 32039, 32052, 32083, 32087, 32097, 32103, 32118, 32123, 32150, 32153, 32154, 32186, 32223, 32226, 32228, 32230, 32231, 32243, 32247, 32255, 32265, 32288, 32289, 32306, 32350, 32375, 32376, 32385, 32387, 32390, 32392, 32413, 32435, 32439, 32452, 32459, 32463, 32474, 32505, 32531, 32533, 32537, 32567, 32584, 32591, 32595, 32603, 32608, 32610, 32631, 32655, 32675, 32684, 32708, 32720, 32727, 32728, 32739, 32748, 32764, 32769, 32776, 32789, 32795, 32799, 32802, 32806, 32807, 32812, 32815, 32816, 32820, 32823, 32832, 32842, 32843, 32844, 32848, 32850, 32871, 32878, 32894, 32897, 32899, 32903, 32905, 32907, 32916, 32925, 32930, 32931, 32938, 32958, 32959, 32964, 32970, 32971, 32974, 32983, 32985, 32988, 32989, 32991, 32992, 32994, 32995, 32998, 33000, 33008, 33010, 33021, 33043, 33051, 33055, 33058, 33060, 33064, 33066, 33067, 33068, 33070, 33071, 33073, 33074, 33082, 33083, 33087, 33088, 33091, 33093, 33097, 33099, 33101, 33103, 33109, 33115, 33117, 33119, 33126, 33128, 33132, 33133, 33136, 33138, 33144, 33148, 33149, 33150, 33156, 33158, 33162, 33163, 33170, 33173, 33177, 33178, 33180, 33182, 33183, 33185, 33186, 33187, 33189, 33190, 33198, 33202, 33205, 33207, 33215, 33218, 33219, 33221, 33222, 33223, 33225, 33227, 33234, 33235, 33240, 33244, 33248, 33251, 33252, 33253, 33254, 33255, 33262, 33264, 33269, 33272, 33274, 33275, 33283, 33287, 33302, 33305, 33312, 33313, 33314, 33318, 33328, 33330, 33334, 33335, 33338, 33340, 33347, 33348, 33364, 33367, 33368, 33369, 33371, 33377, 33382, 33388, 33392, 33393, 33394, 33396, 33398, 33399, 33402, 33404, 33408, 33413, 33423, 33435, 33438, 33449, 33451, 33453, 33459, 33463, 33470, 33471, 33474, 33477, 33478, 33489, 33493, 33497, 33516, 33518, 33523, 33525, 33526, 33527, 33534, 33541, 33543, 33544, 33545, 33547, 33548, 33550, 33553, 33558, 33561, 33562, 33563, 33564, 33565, 33566, 33567, 33570, 33582, 33587, 33591, 33603, 33604, 33608, 33609, 33611, 33625, 33628, 33632, 33635, 33636, 33639, 33648, 33650, 33651, 33655, 33662, 33669, 33673, 33677, 33678, 33679, 33683, 33684, 33686, 33687, 33690, 33692, 33695, 33696, 33699, 33700, 33702, 33704, 33717, 33718, 33722, 33723, 33726, 33740, 33748, 33749, 33750, 33751, 33752, 33755, 33767, 33772, 33775, 33777, 33784, 33785, 33787, 33788, 33789, 33794, 33797, 33805, 33823, 33838, 33839, 33848, 33850, 33854, 33858, 33867, 33897, 33909, 36062, 39068, 72005, 72007, 72008, 72013, 72016, 72019, 72020, 72022, 72032, 72036, 72038, 72040, 72048, 72053, 72055, 72058, 72063, 72066, 72080, 72083, 72100, 72103, 72114, 72118, 72119, 72120, 72124, 72127, 72128, 72131, 72134, 72138, 72139, 72141, 72144, 72149, 72150, 72153, 72154, 72157, 72170, 72173, 72175, 72180, 72185, 72189, 72190, 72192, 72201, 72204, 72208, 72222, 72239, 72240, 72247, 72290, 72306, & 72322.

Distribution pattern

Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Libya, Luxembourg, Malaysia, Malta, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Russian Fed., Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, UAE, Venezuela, Vietnam, & Yemen.

device · product 2 of 7

Achieva 1.5T Conversion

Z-0390-2024
Recall number
Z-0390-2024
Initiated
October 23, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
68 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential component failure in the Gradient Coil could product smoke and/or fire.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential component failure in the Gradient Coil could product smoke and/or fire.

Code information

Product No. 781283 & 781346; UDI-DI: (01)00884838009806(21)39001, (01)00884838009806(21)39027, (01)00884838009806(21)39028, (01)00884838009806(21)39030, (01)00884838009806(21)39032, (01)00884838009806(21)39039, (01)00884838009806(21)39053, (01)00884838009806(21)39059, (01)00884838009806(21)39061, (01)00884838009806(21)39062, (01)00884838009806(21)39064, (01)00884838009806(21)39065, (01)00884838009806(21)39066, (01)00884838009806(21)39067, (01)00884838009806(21)39072, (01)00884838009806(21)39073, (01)00884838009806(21)39074, (01)00884838009806(21)39075, (01)00884838009806(21)39078, (01)00884838009806(21)39080, (01)00884838009806(21)39081, (01)00884838009806(21)39082, (01)00884838009806(21)39083, (01)00884838009806(21)39084, (01)00884838009806(21)39086, (01)00884838009806(21)39088, (01)00884838009806(21)39090, (01)00884838009806(21)39091, (01)00884838009806(21)39093, (01)00884838009806(21)39094, (01)00884838009806(21)39095, (01)00884838009806(21)39097, (01)00884838009806(21)39098, (01)00884838009806(21)39100, (01)00884838009806(21)39102, (01)00884838009806(21)39105, (01)00884838009806(21)39106, (01)00884838009806(21)39107, (01)00884838068469(21)5243, (01)00884838068469(21)5547, (01)00884838068469(21)8020, (01)00884838068469(21)8276, (01)00884838068469(21)8289, (01)00884838068469(21)8361, (01)00884838068469(21)8367, (01)00884838068469(21)8371, (01)00884838068469(21)8415, (01)00884838068469(21)8714, (01)00884838068469(21)8727, (01)00884838068469(21)8740, (01)00884838068469(21)8782, (01)00884838068469(21)10189, (01)00884838068469(21)10194, (01)00884838068469(21)10219, (01)00884838068469(21)10821, (01)00884838068469(21)18505, (01)00884838068469(21)18737, (01)00884838068469(21)75000, (01)00884838068469(21)75003, (01)00884838068469(21)75004, (01)00884838068469(21)75007, (01)00884838068469(21)75008, (01)00884838068469(21)75009, (01)00884838068469(21)75015, (01)00884838068469(21)75031, (01)00884838068469(21)75068, (01)00884838068469(21)75087, (01)00884838068469(21)75092; Serial No. 39001, 39027, 39028, 39030, 39032, 39039, 39053, 39059, 39061, 39062, 39064, 39065, 39066, 39067, 39072, 39073, 39074, 39075, 39078, 39080, 39081, 39082, 39083, 39084, 39086, 39088, 39090, 39091, 39093, 39094, 39095, 39097, 39098, 39100, 39102, 39105, 39106, 39107, 5243, 5547, 8020, 8276, 8289, 8361, 8367, 8371, 8415, 8714, 8727, 8740, 8782, 10189, 10194, 10219, 10821, 18505, 18737, 75000, 75003, 75004, 75007, 75008, 75009, 75015, 75031, 75068, 75087, 75092.

Distribution pattern

Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Libya, Luxembourg, Malaysia, Malta, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Russian Fed., Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, UAE, Venezuela, Vietnam, & Yemen.

device · product 3 of 7

Achieva 1.5T Initial System

Z-0391-2024
Recall number
Z-0391-2024
Initiated
October 23, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential component failure in the Gradient Coil could product smoke and/or fire.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential component failure in the Gradient Coil could product smoke and/or fire.

Code information

Product No. 781178; UDI-DI: N/A; Serial No. 21605, 21695.

Distribution pattern

Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Libya, Luxembourg, Malaysia, Malta, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Russian Fed., Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, UAE, Venezuela, Vietnam, & Yemen.

device · product 4 of 7

Ingenia 1.5T CX

Z-0392-2024
Recall number
Z-0392-2024
Initiated
October 23, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
48 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential component failure in the Gradient Coil could product smoke and/or fire.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential component failure in the Gradient Coil could product smoke and/or fire.

Code information

Product No. 781261 & 781262; UDI-DI: (01)00884838068438(21)77008, (01)00884838068438(21)77016, (01)00884838068438(21)77018, (01)00884838068445(21)77032, (01)00884838068445(21)77034, (01)00884838068445(21)77035, (01)00884838068445(21)77038, (01)00884838068445(21)77040, (01)00884838068445(21)77041, (01)00884838068445(21)77046, (01)00884838068445(21)77049, (01)00884838068445(21)77050, (01)00884838068445(21)77054, (01)00884838068445(21)77056, (01)00884838068445(21)77058, (01)00884838068445(21)77059, (01)00884838068445(21)77061, (01)00884838068445(21)77062, (01)00884838068445(21)77065, (01)00884838068445(21)77066, (01)00884838068445(21)77067, (01)00884838068445(21)77071, (01)00884838068445(21)77072, (01)00884838068445(21)77074, (01)00884838068445(21)77075, (01)00884838068445(21)77078, (01)00884838068445(21)77081, (01)00884838068445(21)77083, (01)00884838068445(21)77084, (01)00884838068445(21)77087, (01)00884838068445(21)77093, (01)00884838068445(21)77094, (01)00884838068445(21)77097, (01)00884838068445(21)77100, (01)00884838068445(21)77101, (01)00884838068445(21)77106, (01)00884838068445(21)77109, (01)00884838068445(21)77110, (01)00884838068445(21)77111, (01)00884838068445(21)77119, (01)00884838068445(21)77120, (01)00884838068445(21)77121, (01)00884838068445(21)77124, (01)00884838068445(21)77126, (01)00884838068445(21)77129, (01)00884838068445(21)77130, (01)00884838068445(21)77131, (01)00884838068445(21)77137; Serial No. 77008, 77016, 77018, 77032, 77034, 77035, 77038, 77040, 77041, 77046, 77049, 77050, 77054, 77056, 77058, 77059, 77061, 77062, 77065, 77066, 77067, 77071, 77072, 77074, 77075, 77078, 77081, 77083, 77084, 77087, 77093, 77094, 77097, 77100, 77101, 77106, 77109, 77110, 77111, 77119, 77120, 77121, 77124, 77126, 77129, 77130, 77131, 77137.

Distribution pattern

Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Libya, Luxembourg, Malaysia, Malta, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Russian Fed., Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, UAE, Venezuela, Vietnam, & Yemen.

device · product 5 of 7

Intera 1.5T

Z-0393-2024
Recall number
Z-0393-2024
Initiated
October 23, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
102 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential component failure in the Gradient Coil could product smoke and/or fire.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential component failure in the Gradient Coil could product smoke and/or fire.

Code information

Product No. 781195 & 781295; UDI-DI: N/A; Serial No. 18510, 18516, 18529, 18550, 18564, 18567, 18578, 18583, 18592, 18657, 18660, 18667, 18678, 18701, 18709, 18711, 18714, 18725, 18727, 18769, 18773, 18776, 18787, 18812, 18820, 18854, 18856, 18857, 18870, 18873, 18878, 18884, 18889, 18890, 18905, 18906, 18907, 18913, 18917, 18920, 18923, 18931, 18935, 18947, 18948, 18950, 18965, 18973, 18986, 18998, 20402, 20403, 20404, 20409, 20426, 20441, 30004, 30030, 30037, 30038, 30064, 30079, 30081, 30082, 30131, 30187, 30190, 30199, 30200, 30206, 30213, 30218, 30219, 30223, 30234, 30235, 30236, 30238, 30255, 30256, 30265, 30266, 30267, 30268, 30272, 30274, 30277, 30278, 30279, 30280, 30281, 30284, 30285, 30288, 30293, 30296, 30297, 30298, 30303, 30311, 30312, 30315.

Distribution pattern

Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Libya, Luxembourg, Malaysia, Malta, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Russian Fed., Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, UAE, Venezuela, Vietnam, & Yemen.

device · product 6 of 7

Intera 1.5T Power/Pulsar

Z-0394-2024
Recall number
Z-0394-2024
Initiated
October 23, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential component failure in the Gradient Coil could product smoke and/or fire.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential component failure in the Gradient Coil could product smoke and/or fire.

Code information

Product No. 781105; UDI-DI: N/A; Serial No. 8187.

Distribution pattern

Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Libya, Luxembourg, Malaysia, Malta, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Russian Fed., Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, UAE, Venezuela, Vietnam, & Yemen.

device · product 7 of 7

SmartPath to dStream for 1.5T

Z-0395-2024
Recall number
Z-0395-2024
Initiated
October 23, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
119 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential component failure in the Gradient Coil could product smoke and/or fire.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential component failure in the Gradient Coil could product smoke and/or fire.

Code information

Product No. 781260 & 782112; UDI-DI: (01)00884838095076(21)5447, (01)00884838095076(21)5463, (01)00884838095076(21)5479, (01)00884838095076(21)5490, (01)00884838095076(21)5537, (01)00884838095076(21)5546, (01)00884838095076(21)8012, (01)00884838095076(21)8025, (01)00884838095076(21)8054, (01)00884838095076(21)8086, (01)00884838095076(21)8087, (01)00884838095076(21)8091, (01)00884838095076(21)8092, (01)00884838095076(21)8110, (01)00884838095076(21)8118, (01)00884838095076(21)8178, (01)00884838095076(21)8260, (01)00884838095076(21)8311, (01)00884838095076(21)8318, (01)00884838095076(21)8365, (01)00884838095076(21)8378, (01)00884838095076(21)8387, (01)00884838095076(21)8392, (01)00884838095076(21)8395, (01)00884838095076(21)8427, (01)00884838095076(21)8554, (01)00884838095076(21)8566, (01)00884838095076(21)8578, (01)00884838095076(21)8611, (01)00884838095076(21)8616, (01)00884838095076(21)8639, (01)00884838095076(21)8642, (01)00884838095076(21)8667, (01)00884838095076(21)8706, (01)00884838095076(21)8713, (01)00884838095076(21)8746, (01)00884838095076(21)8750, (01)00884838095076(21)8752, (01)00884838095076(21)8779, (01)00884838095076(21)8783, (01)00884838095076(21)8786, (01)00884838095076(21)8831, (01)00884838095076(21)8840, (01)00884838095076(21)8851, (01)00884838095076(21)8857, (01)00884838095076(21)8884, (01)00884838095076(21)8895, (01)00884838095076(21)8896, (01)00884838095076(21)8923, (01)00884838095076(21)8942, (01)00884838095076(21)8948, (01)00884838095076(21)9004, (01)00884838095076(21)9013, (01)00884838095076(21)10029, (01)00884838095076(21)10044, (01)00884838095076(21)10075, (01)00884838095076(21)10079, (01)00884838095076(21)10130, (01)00884838095076(21)10151, (01)00884838095076(21)10164, (01)00884838095076(21)10170, (01)00884838095076(21)10174, (01)00884838095076(21)10185, (01)00884838095076(21)10191, (01)00884838095076(21)10458, (01)00884838095076(21)10511, (01)00884838095076(21)10513, (01)00884838095076(21)10554, (01)00884838095076(21)10906, (01)00884838095076(21)10915, (01)00884838095076(21)11031, (01)00884838095076(21)11047, (01)00884838095076(21)11062, (01)00884838095076(21)11076, (01)00884838095076(21)11085, (01)00884838095076(21)11091, (01)00884838095076(21)11102, (01)00884838095076(21)12030, (01)00884838095076(21)13011, (01)00884838095076(21)13029, (01)00884838095076(21)13032, (01)00884838095076(21)13062, (01)00884838095076(21)18038, (01)00884838095076(21)18670, (01)00884838095076(21)18761, (01)00884838095076(21)18957, (01)00884838095076(21)20071, (01)00884838095076(21)20111, (01)00884838095076(21)20226, (01)00884838095076(21)21062, (01)00884838095076(21)21213, (01)00884838095076(21)21576, (01)00884838095076(21)21582, (01)00884838095076(21)21801, (01)00884838095076(21)21814, (01)00884838095076(21)22013, (01)00884838095076(21)22017, (01)00884838095076(21)22031, (01)00884838095076(21)22086, (01)00884838095076(21)22098, (01)00884838095076(21)22102, (01)00884838095076(21)22144, (01)00884838095076(21)22157, (01)00884838095076(21)22248, (01)00884838095076(21)30033, (01)00884838095076(21)32218, (01)00884838095076(21)33044, (01)00884838095076(21)33246, (01)00884838095076(21)39003, (01)00884838095076(21)39024, (01)00884838095076(21)39031, (01)00884838095076(21)39037, (01)00884838095076(21)72054, (01)00884838095076(21)72243, (01)00884838095076(21)72250, (01)00884838098886(21)10128, (01)00884838098886(21)21893, (01)00884838098886(21)32580, (01)00884838098886(21)32798; Serial No. 5447, 5463, 5479, 5490, 5537, 5546, 8012, 8025, 8054, 8086, 8087, 8091, 8092, 8110, 8118, 8178, 8260, 8311, 8318, 8365, 8378, 8387, 8392, 8395, 8427, 8554, 8566, 8578, 8611, 8616, 8639, 8642, 8667, 8706, 8713, 8746, 8750, 8752, 8779, 8783, 8786, 8831, 8840, 8851, 8857, 8884, 8895, 8896, 8923, 8942, 8948, 9004, 9013, 10029, 10044, 10075, 10079, 10130, 10151, 10164, 10170, 10174, 10185, 10191, 10458, 10511, 10513, 10554, 10906, 10915, 11031, 11047, 11062, 11076, 11085, 11091, 11102, 12030, 13011, 13029, 13032, 13062, 18038, 18670, 18761, 18957, 20071, 20111, 20226, 21062, 21213, 21576, 21582, 21801, 21814, 22013, 22017, 22031, 22086, 22098, 22102, 22144, 22157, 22248, 30033, 32218, 33044, 33246, 39003, 39024, 39031, 39037, 72054, 72243, 72250, 10128, 21893, 32580, 32798.

Distribution pattern

Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Libya, Luxembourg, Malaysia, Malta, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Russian Fed., Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, UAE, Venezuela, Vietnam, & Yemen.