Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93509

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 29, 2022
Product types
Device
Classifications
Class II
Statuses
Completed
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

1 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 1

The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.

Z-0576-2024
Recall number
Z-0576-2024
Initiated
March 29, 2022
Classification
Class II
Status
Completed
Recalling firm
Philips North America Llc
Quantity
330 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software issues affecting incorrect image display, error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect image/function during clinical use.

Code information

System Code: 728143 and 728144; UDI: (01)00884838105508(21)34035, (01)00884838105508(21)34029, (01)00884838105508(21)34030, (01)00884838105508(21)550007, (01)00884838105508(21)550009, (01)00884838105508(21)550068, (01)00884838105508(21)550012, (01)00884838105508(21)550044, (01)00884838105508(21)550049, (01)00884838105508(21)34021, (01)00884838105508(21)34076, (01)00884838105508(21)34094, (01)00884838105508(21)500519, (01)00884838105508(21)550024, (01)00884838105508(21)550048, (01)00884838105508(21)550062, (01)00884838105508(21)550003, (01)00884838105508(21)34063, (01)00884838105508(21)550027, (01)00884838105508(21)550029, (01)00884838105508(21)552006, (01)00884838105508(21)552007, (01)00884838105508(21)552009, (01)00884838105508(21)500502, (01)00884838105508(21)550020, (01)00884838085015(21)500367, (01)00884838085015(21)500379, (01)00884838085015(21)500521, (01)00884838085015(21)500138, (01)00884838085015(21)500308, (01)00884838105508(21)34074, (01)00884838105508(21)34102, (01)00884838105508(21)34053, (01)00884838105508(21)34092, (01)00884838105508(21)34008, (01)00884838105508(21)550026, (01)00884838105508(21)34028, (01)00884838105508(21)34039, (01)00884838105508(21)34048, (01)00884838105508(21)34069, (01)00884838085015(21)500110, (01)00884838085015(21)500111, (01)00884838105508(21)34041, (01)00884838105508(21)34036, (01)00884838105508(21)34065, (01)00884838105508(21)34061, (01)00884838085015(21)500433, (01)00884838105508(21)500517, (01)00884838105508(21)550060, (01)00884838105508(21)550061, (01)00884838085015(21)33023, (01)00884838105508(21)34001, (01)00884838085015(21)500443, (01)00884838105508(21)500452, (01)00884838105508(21)550035, (01)00884838105508(21)34004, (01)00884838105508(21)34005, (01)00884838105508(21)500503, (01)00884838105508(21)550042, (01)00884838105508(21)510043, (01)00884838105508(21)552002, (01)00884838105508(21)552005, (01)00884838105508(21)550054, (01)00884838105508(21)550056, (01)00884838105508(21)34081, (01)00884838105508(21)34080, (01)00884838085015(21)500441, (01)00884838085015(21)500338, (01)00884838105508(21)550013, (01)00884838105508(21)552014, (01)00884838105508(21)550041, (01)00884838105508(21)500504, (01)00884838105508(21)500514, (01)00884838105508(21)550006, (01)00884838105508(21)550067, (01)00884838105508(21)34070, (01)00884838085015(21)500030, (01)00884838085015(21)500133, (01)00884838085015(21)500104, (01)00884838105508(21)552013, (01)00884838085015(21)500439, (01)00884838085015(21)500119, (01)00884838085015(21)33018, (01)00884838085015(21)500324, (01)00884838085015(21)500113, (01)00884838105508(21)34034, (01)00884838085015(21)500330, (01)00884838085015(21)500416, (01)00884838085015(21)500321, (01)00884838085015(21)500350, (01)00884838105508(21)34046, (01)00884838085015(21)500163, (01)00884838105508(21)550000, (01)00884838105508(21)500499, (01)00884838085015(21)500146, (01)00884838105508(21)34108, (01)00884838105508(21)510039, (01)00884838105508(21)34037, (01)00884838105508(21)550004, (01)00884838085015(21)500005, (01)00884838085015(21)500019, (01)00884838085015(21)500408, (01)00884838105508(21)550010, (01)00884838105508(21)500515, (01)00884838105508(21)34011, (01)00884838105508(21)550036, (01)00884838105508(21)550008, (01)00884838085015(21)500323, (01)00884838105508(21)34020, (01)00884838105508(21)500530, (01)00884838105508(21)550040, (01)00884838085015(21)500360, (01)00884838085015(21)500470, (01)00884838105508(21)550059, (01)00884838105508(21)550034, (01)00884838105508(21)550025, (01)00884838105508(21)34003, (01)00884838105508(21)34002, (01)00884838105508(21)34075, (01)00884838085015(21)33038, (01)00884838085015(21)33046, (01)00884838085015(21)33012, (01)00884838085015(21)33045, (01)00884838105508(21)34085, (01)00884838105508(21)34006, (01)00884838105508(21)34051, (01)00884838105508(21)34105, (01)00884838085015(21)33041, (01)00884838105508(21)34047, (01)00884838085015(21)33002, (01)00884838105508(21)34033, (01)00884838105508(21)34019, (01)00884838085015(21)33042, (01)00884838105508(21)34083, (01)00884838085015(21)33025, (01)00884838105508(21)34043, (01)00884838085015(21)500396, (01)00884838105508(21)34084, (01)00884838105508(21)500516, (01)00884838105508(21)550065, (01)00884838105508(21)500501, (01)00884838105508(21)500506, (01)00884838085015(21)500475, (01)00884838085015(21)500027, (01)00884838105508(21)550043, (01)00884838085015(21)500401, (01)00884838105508(21)34023, (01)00884838085015(21)500025, (01)00884838105508(21)550021, (01)00884838105508(21)550014, (01)00884838085015(21)500417, (01)00884838085015(21)500322, (01)00884838105508(21)550053, (01)00884838105508(21)510046, (01)00884838105508(21)34107, (01)00884838105508(21)552011, (01)00884838105508(21)550005, (01)00884838105508(21)500536, (01)00884838105508(21)34079, (01)00884838105508(21)550066, (01)00884838105508(21)550033, (01)00884838105508(21)550019, (01)00884838105508(21)34067, (01)00884838105508(21)34031, (01)00884838085015(21)33034, (01)00884838105508(21)34032, (01)00884838105508(21)34072, (01)00884838105508(21)500531, (01)00884838085015(21)500411, (01)00884838105508(21)34082, (01)00884838085015(21)500476, (01)00884838105508(21)552000, (01)00884838105508(21)500505, (01)00884838085015(21)33019, (01)00884838105508(21)34071, (01)00884838105508(21)34106, (01)00884838085015(21)33020, (01)00884838085015(21)33021, (01)00884838085015(21)500473, (01)00884838105508(21)550051, (01)00884838085015(21)500358, (01)00884838085015(21)500270, (01)00884838085015(21)500319, (01)00884838085015(21)500215, (01)00884838085015(21)500313, (01)00884838085015(21)500271, (01)00884838085015(21)500071, (01)00884838105508(21)34009, (01)00884838105508(21)550046, (01)00884838085015(21)33029, (01)00884838105508(21)550032, (01)00884838085015(21)500316, (01)00884838105508(21)500454, (01)00884838085015(21)500462, (01)00884838085015(21)500430, (01)00884838085015(21)33010, (01)00884838085015(21)510013, (01)00884838085015(21)500037, (01)00884838105508(21)34050, (01)00884838105508(21)550016, (01)00884838085015(21)33031, (01)00884838085015(21)500477, (01)00884838085015(21)33037, (01)00884838105508(21)34089, (01)00884838085015(21)500421, (01)00884838105508(21)550050, (01)00884838105508(21)550001, (01)00884838105508(21)552008, (01)00884838085015(21)500082, (01)00884838105508(21)500509, (01)00884838085015(21)500356, (01)00884838105508(21)550047, (01)00884838085015(21)500243, (01)00884838105508(21)34078, (01)00884838085015(21)500007, (01)00884838085015(21)500060, (01)00884838105508(21)34088, (01)00884838085015(21)500343, (01)00884838085015(21)500425, (01)00884838085015(21)500365, (01)00884838085015(21)500328, (01)00884838105508(21)34073, (01)00884838105508(21)500453, (01)00884838105508(21)34057, (01)00884838105508(21)500511, (01)00884838085015(21)500236, (01)00884838105508(21)34016, (01)00884838085015(21)500246, (01)00884838105508(21)550069, (01)00884838105508(21)552003, (01)00884838105508(21)34054, (01)00884838105508(21)34040, (01)00884838085015(21)500192, (01)00884838105508(21)550022, (01)00884838105508(21)34104, (01)00884838105508(21)550058, (01)00884838105508(21)34062, (01)00884838105508(21)500512, (01)00884838105508(21)500507, (01)00884838105508(21)500537, (01)00884838085015(21)500553, (01)00884838105508(21)34027, (01)00884838105508(21)510040, (01)00884838085015(21)500298, (01)00884838085015(21)500387, (01)00884838085015(21)33040, (01)00884838085015(21)33030, (01)00884838105508(21)550055, (01)00884838085015(21)500568, (01)00884838105508(21)550011, (01)00884838105508(21)510045, (01)00884838105508(21)510047, (01)00884838105508(21)550028, (01)00884838105508(21)552012, (01)00884838105508(21)550038, (01)00884838085015(21)500320, (01)00884838105508(21)550064, (01)00884838105508(21)34025, (01)00884838085015(21)500124, (01)00884838085015(21)500398, (01)00884838085015(21)500374, (01)00884838105508(21)550070, (01)00884838105508(21)34101, (01)00884838085015(21)500461, (01)00884838105508(21)552001, (01)00884838105508(21)550002, (01)00884838085015(21)500431, (01)00884838105508(21)550018, (01)00884838105508(21)34103, (01)00884838105508(21)34077, (01)00884838105508(21)34090, (01)00884838105508(21)34045, (01)00884838105508(21)550023, (01)00884838085015(21)500383, (01)00884838105508(21)34038, (01)00884838105508(21)34022, (01)00884838085015(21)500283, (01)00884838105508(21)34066, (01)00884838085015(21)500494, (01)00884838105508(21)552004, (01)00884838105508(21)550057, (01)00884838105508(21)34042, (01)00884838085015(21)500259, (01)00884838085015(21)500418, (01)00884838105508(21)500538, (01)00884838105508(21)550063, (01)00884838105508(21)500508, (01)00884838105508(21)500518, (01)00884838105508(21)500500, (01)00884838085015(21)500513, (01)00884838105508(21)34064, (01)00884838085015(21)33033, (01)00884838105508(21)34018, (01)00884838105508(21)34010, (01)00884838105508(21)34086, (01)00884838105508(21)34014, (01)00884838105508(21)500529, (01)00884838105508(21)34013, (01)00884838105508(21)500520, (01)00884838105508(21)550017, (01)00884838105508(21)550030, (01)00884838105508(21)34068, (01)00884838105508(21)550037, (01)00884838085015(21)500381, (01)00884838105508(21)550052, (01)00884838105508(21)34007, (01)00884838105508(21)550039, (01)00884838105508(21)34015, (01)00884838105508(21)550045, (01)00884838105508(21)552010, (01)00884838105508(21)34026, (01)00884838085015(21)500533, (01)00884838105508(21)34044, (01)00884838105508(21)34087, (01)00884838105508(21)34093, (01)00884838105508(21)34095, (01)00884838105508(21)34058, (01)00884838105508(21)34024, (01)00884838105508(21)34059, (01)00884838105508(21)34049, (01)00884838105508(21)34056, (01)00884838105508(21)550015, (01)00884838105508(21)34055, (01)00884838105508(21)550031, (01)00884838085015(21)540020, (01)00884838105508(21)34091, (01)00884838105508(21)34052, (01)00884838105508(21)34060, (01)00884838105508(21)34100, (01)00884838105508(21)34097; Equipment Number: 97127344, 97127351, 97127346, 94808779, 94878276, 94808780, 94984190, 96161875, 96457814, 97598528, 99349025, 100353722, 94660960, 96506383, 96483951, 96454302, 95085734, 96621291, 95887893, 95984533, 97265085, 97320687, 97465137, 93909674, 95205133, 83541355, 83541960, 91681806, 83706469, 88315478, 99159836, 100665288, 98684958, 100221507, 96160762, 96000308, 96236084, 96621180, 96621365, 96619792, 83719826, 83720363, 98381573, 98167941, 97545869, 98561529, 92797435, 93514492, 97565570, 97582080, 93333252, 95510387, 93333254, 93575188, 96579399, 96556290, 96556291, 93682738, 96281213, 94354758, 93642574, 96787786, 96454720, 96454495, 99291318, 99291325, 92876933, 89450377, 93498323, 94044961, 95526392, 94080858, 93906704, 95019847, 96493777, 97616466, 82548602, 85711601, 85186365, 96468417, 92870027, 85469672, 92889235, 89504577, 84019318, 96451923, 89702922, 91926976, 89430835, 89915190, 96470333, 84799014, 94655384, 93496318, 85146962, 98791232, 94075767, 96436137, 94637834, 76844348, 80174381, 82017500, 94604476, 94751785, 96179883, 95808825, 94325563, 89297104, 96369805, 94305367, 95468396, 89228480, 92953643, 96364755, 95505799, 94906272, 96793435, 96470439, 99258404, 95033805, 92696776, 89506890, 95370037, 99367503, 96913762, 98530110, 100685830, 94933279, 98531980, 89496008, 97922129, 97642170, 95116211, 99348732, 93661754, 97375282, 89522790, 98347534, 94713152, 94696231, 93662882, 94691307, 93728239, 81731047, 95392934, 89777001, 97662063, 80150974, 94878278, 94860877, 91996730, 89473934, 96486169, 93665063, 100624570, 96135594, 94715511, 94362635, 99233532, 95006715, 95964493, 93641555, 99089303, 97848079, 94265606, 98150759, 99017606, 93664936, 91928837, 99290345, 93849561, 93643679, 93415171, 93098630, 99143439, 100620944, 92160634, 92868072, 93317501, 96282297, 89430151, 88120593, 89913439, 86687392, 89430831, 88121897, 81663416, 96236045, 96161527, 93552884, 96024573, 89430838, 93477700, 92823844, 92157218, 92693958, 91465483, 81492478, 98586858, 95441585, 95055302, 92865256, 95362963, 100278599, 92158516, 95720317, 94715154, 96016654, 82875264, 93387812, 89429360, 95152504, 87225967, 99233514, 76736410, 83310826, 100143393, 89430152, 89504402, 89472305, 89207448, 99159877, 93362293, 98772950, 93954868, 87226997, 96483025, 87227046, 96449129, 95113128, 98688573, 98484415, 85762575, 95156158, 100603388, 97433240, 98809044, 94590931, 93648090, 94811297, 95267211, 96467905, 93644014, 88470073, 92047046, 95845378, 93529093, 97433198, 96483049, 96001922, 95601637, 95600746, 96483103, 97714356, 96809322, 89316872, 97582219, 97550594, 84806473, 86890110, 89503429, 96828713, 100682852, 88208685, 95888654, 93666793, 92085956, 95512911, 100596674, 99290329, 100149814, 97069242, 95504632, 89842270, 98381570, 96395095, 88184662, 98971567, 94084434, 95676419, 97508811, 98484413, 86661414, 92083044, 93516684, 95986806, 93363033, 93518591, 93669386, 94316241, 98971554, 95131295, 97642190, 94500597, 100217205, 94814415, 94664159, 94814472, 93642949, 96215982, 95110174, 99089359, 96580906, 89997864, 96327577, 97014625, 96067612, 96377639, 96774006, 96927365, 97601484, 94929536, 96451802, 96997201, 100274967, 100521925, 98792250, 96492248, 98875082, 98594817, 98689355, 94533039, 98778986, 96132004, 98878526, 100237214, 98597398, 98779045, 100603730, 100598724; Serial No. 34035, 34029, 34030, 550007, 550009, 550068, 550012, 550044, 550049, 34021, 34076, 34094, 500519, 550024, 550048, 550062, 550003, 34063, 550027, 550029, 552006, 552007, 552009, 500502, 550020, 500367, 500379, 500521, 500138, 500308, 34074, 34102, 34053, 34092, 34008, 550026, 34028, 34039, 34048, 34069, 500110, 500111, 34041, 34036, 34065, 34061, 500433, 500517, 550060, 550061, 33023, 34001, 500443, 500452, 550035, 34004, 34005, 500503, 550042, 510043, 552002, 552005, 550054, 550056, 34081, 34080, 500441, 500338, 550013, 552014, 550041, 500504, 500514, 550006, 550067, 34070, 500030, 500133, 500104, 552013, 500439, 500119, 33018, 500324, 500113, 34034, 500330, 500416, 500321, 500350, 34046, 500163, 550000, 500499, 500146, 34108, 510039, 34037, 550004, 500005, 500019, 500408, 550010, 500515, 34011, 550036, 550008, 500323, 34020, 500530, 550040, 500360, 500470, 550059, 550034, 550025, 34003, 34002, 34075, 33038, 33046, 33012, 33045, 34085, 34006, 34051, 34105, 33041, 34047, 33002, 34033, 34019, 33042, 34083, 33025, 34043, 500396, 34084, 500516, 550065, 500501, 500506, 500475, 500027, 550043, 500401, 34023, 500025, 550021, 550014, 500417, 500322, 550053, 510046, 34107, 552011, 550005, 500536, 34079, 550066, 550033, 550019, 34067, 34031, 33034, 34032, 34072, 500531, 500411, 34082, 500476, 552000, 500505, 33019, 34071, 34106, 33020, 33021, 500473, 550051, 500358, 500270, 500319, 500215, 500313, 500271, 500071, 34009, 550046, 33029, 550032, 500316, 500454, 500462, 500430, 33010, 510013, 500037, 34050, 550016, 33031, 500477, 33037, 34089, 500421, 550050, 550001, 552008, 500082, 500509, 500356, 550047, 500243, 34078, 500007, 500060, 34088, 500343, 500425, 500365, 500328, 34073, 500453, 34057, 500511, 500236, 34016, 500246, 550069, 552003, 34054, 34040, 500192, 550022, 34104, 550058, 34062, 500512, 500507, 500537, 500553, 34027, 510040, 500298, 500387, 33040, 33030, 550055, 500568, 550011, 510045, 510047, 550028, 552012, 550038, 500320, 550064, 34025, 500124, 500398, 500374, 550070, 34101, 500461, 552001, 550002, 500431, 550018, 34103, 34077, 34090, 34045, 550023, 500383, 34038, 34022, 500283, 34066, 500494, 552004, 550057, 34042, 500259, 500418, 500538, 550063, 500508, 500518, 500500, 500513, 34064, 33033, 34018, 34010, 34086, 34014, 500529, 34013, 500520, 550017, 550030, 34068, 550037, 500381, 550052, 34007, 550039, 34015, 550045, 552010, 34026, 500533, 34044, 34087, 34093, 34095, 34058, 34024, 34059, 34049, 34056, 550015, 34055, 550031, 540020, 34091, 34052, 34060, 34100, 34097.

Distribution pattern

Domestic: AL, AR, AZ, CA, FL, GA, HI, IL, IN, KY, LA, MD, ME, MI, MS, NC, NJ, NM, NY, OH, OK, PA, RI, TN, TX; Foreign: Albania, Argentina, Australia, Austria, Bolivia, Bosnia-Herzegovina , Cambodia, Canada, Chile, Colombia, Costa Rica, Czech Republic, Ecuador, Egypt, Ethiopia, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kenya, Kosovo, Lao People's Democratic Republic, Latvia, Lebanon, Moldova, Morocco, Netherlands, Palestine, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russian Federation, Saint Lucia, Saint Pierre and Miquelon, Sint Maarten , South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Viet Nam.