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Incisive CT recallZ-0576-2024 · Philips North America Llc · initiated Mar 29, 2022

Class II Completed All recalls posted in December 2023

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

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.

FDA root cause category: Software design

What the company is doing

Customers were sent IMPORTANT PRODUCT NOTICE letters dated 03/29/2022 via USPS. Consignees were asked to identify any affected devices at their facility utilizing the provided instructions, refer to the provided Appendix A for specific details regarding the three issue descriptions and work arounds provided to customers, place the notice with the documentation of the system until all issues have been resolved, and circulate this notice to all users of this device so that they are aware. A Philips Field Service Engineer will contact consignees to schedule a software upgrade. Customers with any questions can contact their local Philips representative and reference FCO72800772 or contact the Customer Care Solutions Center at 1-800-722-9377.

Recall details

Recall number
Z-0576-2024
Recall class
Class II
Status
Completed
Initiated by the company
Mar 29, 2022
Posted by the FDA
Dec 18, 2023
Recalling firm
Philips North America Llc
Quantity
330 units
Product code
JAK
FDA submissions
K212441, K180015
Distribution
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.

Product description

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.

Code information (models, lots, serial numbers)

Show the full code information (16k characters)

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, 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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.

Devices named in this recall

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

Product lines

Sources and updates

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