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RecallWatchMedical Device Safety
Class IIOngoingZ-1660-2025

Philips North America LLC recalls Philips Brilliance CT Big Bore

Philips North America LlcCambridge, MA, United StatesReported Apr 30, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

Lot / code information

Model
728242, 728243, 728244
UDI
(01)00884838098725(21)7014, (01)00884838098725(21)7032, (01)00884838059450(21)7056, (01)00884838098725(21)7060, (01)00884838098725(21)7062, (01)00884838098725(21)7064 — +561 moreShow all
(01)00884838098725(21)7014, (01)00884838098725(21)7032, (01)00884838059450(21)7056, (01)00884838098725(21)7060, (01)00884838098725(21)7062, (01)00884838098725(21)7064, (01)00884838098725(21)7072, (01)00884838098725(21)7087, (01)00884838059450(21)7096, (01)00884838059450(21)7123, (01)00884838059450(21)7124, (01)00884838098725(21)7128, (01)00884838098725(21)7135, (01)00884838098725(21)7154, (01)00884838098725(21)7163, (01)00884838098725(21)7179, (01)00884838098725(21)7191, (01)00884838098725(21)7220, (01)00884838098725(21)7221, (01)00884838098725(21)7229, (01)00884838059450(21)7240, (01)00884838098725(21)7245, (01)00884838098725(21)7246, (01)00884838098725(21)7247, (01)00884838098725(21)7254, (01)00884838098725(21)7256, (01)00884838098725(21)7282, (01)00884838098725(21)7283, (01)00884838098725(21)7292, (01)00884838098725(21)7297, (01)00884838098725(21)7304, (01)00884838098725(21)7306, (01)00884838098725(21)7309, (01)00884838098725(21)7311, (01)00884838098725(21)7331, (01)00884838098725(21)7332, (01)00884838059450(21)7333, (01)00845225003036(10)0302624730(21)7336, (01)00845225003036(10)0302624730(21)7341, (01)00845225003036(10)0302624730(21)7345, (01)00845225003036(10)0302624730(21)7348, (01)00845225003036(10)0302624730(21)7353, (01)00884838059450(21)7355, (01)00884838059450(21)7362, (01)00845225003036(10)0302624730(21)7364, (01)00845225003036(10)0302624730(21)7367, (01)00845225003036(10)0302624730(21)7373, (01)00884838098725(21)7396, (01)00845225003036(10)0302624730(21)7401, (01)00845225003036(10)0302624730(21)7406, (01)00884838098725(21)7410, (01)00845225003036(10)0302624730(21)7414, (01)00845225003036(10)0302624730(21)7421, (01)00884838098725(21)7429, (01)00884838098725(21)7441, (01)00845225003036(10)0302624730(21)7442, (01)00845225003036(10)0302624730(21)7443, (01)00884838059450(21)7449, (01)00845225003036(10)0302624730(21)7455, (01)00845225003036(10)0302624730(21)7464, (01)00884838059450(21)7470, (01)00845225003036(10)0302624730(21)7472, (01)00884838098725(21)7486, (01)00884838098725(21)7497, (01)00845225003036(10)0302624730(21)7498, (01)00845225003036(10)0302624730(21)7500, (01)00884838098725(21)7508, (01)00845225003036(10)0302624730(21)7509, (01)00884838059450(21)7521, (01)00845225003036(10)0302624730(21)7535, (01)00845225003036(10)0302624730(21)7541, (01)00884838098725(21)7542, (01)00884838098725(21)7543, (01)00845225003036(10)0302624730(21)7554, (01)00845225003036(10)0302624730(21)7555, (01)00845225003036(10)0302624730(21)7565, (01)00845225003036(10)0302624730(21)7566, (01)00884838059450(21)7569, (01)00845225003036(10)0302624730(21)7570, (01)00845225003036(10)0302624730(21)7572, (01)00845225003036(10)0302624730(21)7573, (01)00884838059450(21)7575, (01)00845225003036(10)0302624730(21)7576, (01)00845225003036(10)0302624730(21)7578, (01)00845225003036(10)0302624730(21)7586, (01)00845225003036(10)0302624730(21)7594, (01)00845225003036(10)0302624730(21)7598, (01)00845225003036(10)0302624730(21)7600, (01)00845225003036(10)0302624730(21)7602, (01)00845225003036(10)0302652289(21)7618, (01)00845225003036(10)0302652289(21)7623, (01)00845225003036(10)0302652289(21)7625, (01)00845225003036(10)0302652289(21)7626, (01)00845225003036(10)0302652289(21)7633, (01)00845225003036(10)0302652289(21)7637, (01)00845225003036(10)0302652289(21)7645, (01)00884838098725(21)7646, (01)00845225003036(10)0302652289(21)7652, (01)00845225003036(10)0302652289(21)7653, (01)00845225003036(10)0302652289(21)7654, (01)00884838098725(21)7659, (01)00845225003036(10)0302652289(21)7660, (01)00845225003036(10)0302652289(21)7662, (01)00845225003036(10)0302652289(21)7670, (01)00845225003036(10)0302652289(21)7671, (01)00845225003036(10)0302652289(21)7674, (01)00845225003036(10)0302652289(21)7675, (01)00884838059450(21)7677, (01)00845225003036(10)0302652289(21)7679, (01)00845225003036(10)0302652289(21)7683, (01)00884838059450(21)7684, (01)00845225003036(10)0302652289(21)7686, (01)00884838098725(21)7689, (01)00845225003036(10)0302652289(21)7692, (01)00845225003036(10)0302652289(21)7695, (01)00884838098725(21)7698, (01)00884838059450(21)7699, (01)00884838098725(21)7708, (01)00845225003036(10)0302652289(21)7710, (01)00884838098725(21)7711, (01)00845225003036(10)0302652289(21)7714, (01)00884838098725(21)7716, (01)00884838098725(21)7721, (01)00845225003036(10)0302652289(21)7722, (01)00845225003036(10)0302652289(21)7732, (01)00845225003036(10)0302652289(21)7742, (01)00845225003036(10)0302652289(21)7747, (01)00884838059450(21)7751, (01)00845225003036(10)0302652289(21)7756, (01)00884838098725(21)7757, (01)00845225003036(10)0302652289(21)7758, (01)00845225003036(10)0302652289(21)7760, (01)00845225003036(10)0302652289(21)7762, (01)00845225003036(10)0302652289(21)7765, (01)00845225003036(10)0302652289(21)7766, (01)00845225003036(10)0302652289(21)7772, (01)00845225003036(10)0302652289(21)7776, (01)00884838098725(21)7780, (01)00845225003036(10)0302652289(21)7782, (01)00845225003036(10)0302652289(21)7783, (01)00845225003036(10)0302652289(21)7793, (01)00845225003036(10)0302652289(21)7794, (01)00845225003036(10)0302652289(21)7802, (01)00845225003036(10)0302668752(21)7821, (01)00845225003036(10)0302668752(21)7825, (01)00845225003036(10)0302668752(21)7826, (01)00845225003036(10)0302668752(21)7830, (01)00845225003036(10)0302668752(21)7833, (01)00845225003036(10)0302668752(21)7834, (01)00845225003036(10)0302668752(21)7840, (01)00845225003036(10)0302668752(21)7843, (01)00845225003036(10)0302668752(21)7844, (01)00845225003036(10)0302668752(21)7852, (01)00845225003036(10)0302668752(21)7854, (01)00845225003036(10)0302668752(21)7867, (01)00845225003036(10)0302668752(21)7868, (01)00845225003036(10)0302668752(21)7869, (01)00845225003036(10)0302668752(21)7870, (01)00845225003036(10)0302668752(21)7871, (01)00884838059450(21)7879, (01)00845225003036(10)0302668752(21)7884, (01)00845225003036(10)0302668752(21)7886, (01)00845225003036(10)0302668752(21)7887, (01)00884838098725(21)7889, (01)00845225003036(10)0302668752(21)7890, (01)00884838059450(21)7897, (01)0084 …
Serial #
7013, 7014, 7032, 7034, 7038, 7056 — +638 moreShow all
7013, 7014, 7032, 7034, 7038, 7056, 7058, 7060, 7062, 7064, 7068, 7072, 7076, 7081, 7087, 7096, 7097, 7099, 7104, 7123, 7124, 7128, 7135, 7137, 7138, 7148, 7152, 7154, 7157, 7162, 7163, 7173, 7177, 7179, 7191, 7196, 7203, 7212, 7220, 7221, 7229, 7231, 7240, 7243, 7245, 7246, 7247, 7254, 7256, 7258, 7267, 7282, 7283, 7285, 7292, 7297, 7298, 7299, 7300, 7301, 7304, 7306, 7309, 7311, 7326, 7327, 7329, 7331, 7332, 7333, 7336, 7341, 7345, 7347, 7348, 7353, 7355, 7362, 7364, 7367, 7373, 7385, 7396, 7398, 7401, 7406, 7410, 7413, 7414, 7421, 7429, 7441, 7442, 7443, 7449, 7455, 7464, 7466, 7470, 7472, 7481, 7486, 7497, 7498, 7499, 7500, 7504, 7508, 7509, 7521, 7524, 7525, 7526, 7535, 7538, 7541, 7542, 7543, 7548, 7554, 7555, 7562, 7565, 7566, 7569, 7570, 7572, 7573, 7574, 7575, 7576, 7578, 7586, 7593, 7594, 7598, 7600, 7602, 7612, 7618, 7623, 7625, 7626, 7631, 7633, 7636, 7637, 7645, 7646, 7652, 7653, 7654, 7659, 7660, 7662, 7670, 7671, 7674, 7675, 7677, 7679, 7683, 7684, 7686, 7689, 7692, 7695, 7698, 7699, 7708, 7710, 7711, 7714, 7716, 7721, 7722, 7732, 7742, 7747, 7751, 7756, 7757, 7758, 7760, 7762, 7765, 7766, 7767, 7772, 7776, 7780, 7782, 7783, 7792, 7793, 7794, 7802, 7821, 7825, 7826, 7830, 7833, 7834, 7840, 7843, 7844, 7852, 7854, 7867, 7868, 7869, 7870, 7871, 7879, 7880, 7884, 7886, 7887, 7889, 7890, 7897, 7899, 7900, 7903, 7907, 7909, 7913, 7917, 7918, 7919, 7926, 7930, 7934, 7940, 7946, 7955, 7958, 7959, 7971, 7972, 7975, 7976, 7977, 7978, 7981, 7984, 7990, 7991, 7992, 7993, 7995, 7996, 8002, 8007, 20001, 20002, 20003, 20004, 20005, 20006, 20007, 20008, 20009, 20010, 20011, 20012, 20013, 20014, 20015, 20016, 20017, 20018, 20019, 20020, 20021, 20022, 20023, 20024, 20025, 20026, 20027, 20028, 20029, 20030, 20031, 20032, 20033, 20034, 20035, 20036, 20037, 20038, 20039, 20040, 20041, 20042, 20043, 20044, 20045, 20046, 20047, 20048, 20049, 20050, 20051, 20052, 20053, 20054, 20055, 20056, 20057, 20058, 20059, 20060, 20061, 20063, 20064, 20065, 20066, 20067, 20068, 20069, 20070, 20071, 20072, 20073, 20074, 20075, 20076, 20077, 20078, 20079, 20080, 20081, 20082, 20083, 20084, 20085, 20086, 20087, 20088, 20089, 20090, 20091, 20092, 20093, 20094, 20095, 20096, 20097, 20098, 20099, 20100, 20101, 20102, 20103, 20104, 20105, 20106, 20107, 20108, 20109, 20110, 20111, 20112, 20113, 20114, 20115, 20116, 20118, 75008, 75042, 75043, 75044, 75045, 75051, 75057, 75105, 75107, 75112, 75114, 75115, 75132, 76001, 76005, 76015, 76020, 76021, 76037, 76038, 76040, 76041, 76044, 76046, 76050, 76072, 76075, 76076, 76113, 76117, 76122, 76125, 76133, 76134, 76137, 76140, 76164, 76182, 76190, 76195, 76199, 76219, 76224, 76236, 76237, 76239, 76255, 76271, 76285, 76290, 750010, 750012, 750017, 760012, 760019, 760021, 760023, 760038, 760045, 760047, 760056, 760064, 760075, 760079, 760081, 763000, 763003, 763004, 763005, 763006, 763007, 763008, 763009, 763010, 763011, 763012, 763013, 763014, 763015, 763016, 763017, 763018, 763019, 763020, 763021, 763022, 763023, 763024, 763025, 763026, 763027, 763028, 763029, 763030, 763031, 763032, 763033, 763034, 763035, 763036, 763037, 763038, 763039, 763040, 766001, 766002, 766003, 766004, 766005, 766006, 766007, 766008, 766009, 766010, 766011, 766012, 766013, 766014, 766015, 766016, 766017, 766018, 766019, 766020, 766021, 766022, 766023, 766024, 766025, 766026, 766027, 766028, 766029, 766030, 766031, 766032, 766033, 766034, 766035, 766036, 766037, 766038, 766039, 766040, 766041, 766042, 766043, 766044, 766045, 766046, 766047, 766048, 766049, 766050, 766051, 766052, 766053, 766054, 766055, 766056, 766057, 766058, 766059, 766060, 766061, 766062, 766063, 766064, 766065, 766066, 766067, 766068, 766069, 766070, 766071, 766072, 766073, 766074, 766075, 766076, 766077, 766078, 766079, 766080, 766081, 766082, 766083, 766084, 766085, 766086, 766087, 766088, 766089, 766090, 766091, 766092, 766093, 766094, 766095, 766096, 766097, 766098, 766099, 766100, 766101, 766102, 766103, 766104, 766105, 766106, 766107, 766108, 766109, 766110, 766111, 766112, 766113, 766114, 766115, 766116, 766117, 766118, 766119, 766120, 766121, 766122, 766123, 766124, 766125, 766126, 766127, 766128, 766129, 766130, 766131, 766132, 766133, 766134, 766135, 766136, 766137, 766138, 766139, 766140, 766141, 766142, 766143, 766144, 766145, 766146, 766147, 768000, 768001, 768002, 768003, 768004, 768005, 768006, 768007, 768008, 768009, 768010, 768011, 768012, 768013, 768014, 768015, 768016, 768017, 768018, 768019, 768020, 768021, 768022

What the firm is doing

An "URGENT Medical Device Correction" Notice dated 4/1/25 was mailed to consignees. The notice instructs consignees on how to identify if their unit is affected by this recall. Consignees are instructed to continue use of affected devices by following the recommended actions outlined in the notice and Appendix A. Consignees are asked to return the completed URGENT Medical Device Correction Response Form within 30 days of notification of this recall event via email: Philips.Recall@philips.com. The recall notification is to be circulated among users and retained near affected devices until the update is installed. Philips will be contacting consignees to schedule a Field Service Engineer to visit affected sites and install the update (FCO72800825). Consignees with any questions are to call the Customer Care Solutions Center at 1-800-722-9377.

DistributionShow details

Worldwide distribution: US (Nationwide); and OUS (Foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, China, Czech Republic, Estonia, France, Germany, Honduras, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Lebanon, Libya, Luxembourg, Mauritius, Mexico, Monaco, Morocco, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Puerto Rico, R¿union, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, T¿rkiye, Turkmenistan, United Kingdom, UAE & Yemen.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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