Recall archive / FDA device enforcement
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System. — FDA record Z-1660-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 1, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
- Reason
- Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.
- Classification
- Class II
- Recalling firm
- Philips North America Llc
- Quantity
- 630 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1660-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model No. 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, (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)00845225003036(10)0302668752(21)7899, (01)00884838098725(21)7900, (01)00845225003036(10)0302668752(21)7903, (01)00845225003036(10)0302668752(21)7907, (01)00884838098725(21)7909, (01)00884838098725(21)7913, (01)00884838098725(21)7918, (01)00845225003036(10)0302668752(21)7919, (01)00845225003036(10)0302668752(21)7926, (01)00845225003036(10)0302668752(21)7930, (01)00845225003036(10)0302668752(21)7934, (01)00845225003036(10)0302668752(21)7940, (01)00884838098725(21)7946, (01)00845225003036(10)0302668752(21)7955, (01)00845225003036(10)0302668752(21)7958, (01)00845225003036(10)0302668752(21)7959, (01)00884838098725(21)7971, (01)00845225003036(10)0302668752(21)7972, (01)00845225003036(10)0302668752(21)7975, (01)00845225003036(10)0302668752(21)7976, (01)00845225003036(10)0302668752(21)7977, (01)00884838098725(21)7978, (01)00845225003036(10)0302668752(21)7981, (01)00884838098725(21)7984, (01)00845225003036(10)0302668752(21)7991, (01)00845225003036(10)0302668752(21)7992, (01)00845225003036(10)0302668752(21)7993, (01)00845225003036(10)0302668752(21)7995, (01)00845225003036(10)0302668752(21)7996, (01)00845225003036(10)0302668752(21)8002, (01)00845225003036(10)0302668752(21)8007, (01)00884838095168(21)20008, (01)00884838095168, (01)00884838095168, (01)00884838095168, (01)00884838095168, (01)00884838095168, (01)00884838095168, (01)00884838095168, (01)00884838095168, (01)00884838095168, (01)00884838095168, (01)00884838095168(21)20024, (01)00884838095168(21)20025, (01)00884838095168(21)20026, (01)00884838095168(21)20027, (01)00884838095168(21)20028, (01)00884838095168(21)20029, (01)00884838095168(21)20030, (01)00884838095168(21)20031, (01)00884838095168(21)20032, (01)00884838095168(21)20033, (01)00884838095168(21)20034, (01)00884838095168(21)20035, (01)00884838095168(21)20036, (01)00884838095168(21)20037, (01)00884838095168(21)20038, (01)00884838095168(21)20039, (01)00884838095168(21)20040, (01)00884838095168(21)20041, (01)00884838095168(21)20042, (01)00884838095168(21)20043, (01)00884838095168(21)20044, (01)00884838095168(21)20045, (01)00884838095168(21)20046, (01)00884838095168(21)20047, (01)00884838095168(21)20048, (01)00884838095168(21)20049, (01)00884838095168(21)20050, (01)00884838095168(21)20051, (01)00884838095168(21)20052, (01)00884838095168(21)20053, (01)00884838095168(21)20054, (01)00884838095168(21)20055, (01)00884838095168(21)20056, (01)00884838095168(21)20057, (01)00884838095168(21)20058, (01)00884838095168(21)20059, (01)00884838095168(21)20060, (01)00884838095168(21)20061, (01)00884838095168(21)20063, (01)00884838095168(21)20064, (01)00884838095168(21)20065, (01)00884838095168(21)20066, (01)00884838095168(21)20067, (01)00884838095168(21)20068, (01)00884838095168(21)20069, (01)00884838095168(21)20070, (01)00884838095168(21)20071, (01)00884838095168(21)20072, (01)00884838095168(21)20073, (01)00884838095168(21)20074, (01)00884838095168(21)20075, (01)00884838095168(21)20076, (01)00884838095168(21)20077, (01)00884838095168(21)20078, (01)00884838095168(21)20079, (01)00884838095168(21)20080, (01)00884838095168(21)20081, (01)00884838095168(21)20082, (01)00884838095168(21)20083, (01)00884838095168(21)20084, (01)00884838095168(21)20085, (01)00884838095168(21)20086, (01)00884838095168(21)20087, (01)00884838095168(21)20088, (01)00884838095168(21)20089, (01)00884838095168(21)20090, (01)00884838095168(21)20091, (01)00884838095168(21)20092, (01)00884838095168(21)20093, (01)00884838095168(21)20094, (01)00884838095168(21)20095, (01)00884838095168(21)20096, (01)00884838095168(21)20097, (01)00884838095168(21)20098, (01)00884838095168(21)20099, (01)00884838095168(21)20100, (01)00884838095168(21)20101, (01)00884838095168(21)20102, (01)00884838095168(21)20103, (01)00884838095168(21)20104, (01)00884838095168(21)20105, (01)00884838095168(21)20106, (01)00884838095168(21)20107, (01)00884838095168(21)20108, (01)00884838095168(21)20109, (01)00884838095168(21)20110, (01)00884838095168(21)20111, (01)00884838095168(21)20112, (01)00884838095168(21)20113, (01)00884838095168(21)20114, (01)00884838095168(21)20115, (01)00884838095168(21)20116, (01)00884838095168(21)20118, (01)00884838098725(21)75008, (01)00884838098725(21)75042, (01)00884838098725(21)75043, (01)00884838098725(21)75044, (01)00845225003050(21)75045, (01)00884838098725(21)75051, (01)00884838098725(21)75057, (01)00884838098725(21)75105, (01)00884838098725(21)75107, (01)00884838101142(21)75112, (01)00845225003050(21)75114, (01)00884838098725(21)75132, (01)00884838098725(21)76005, (01)00884838059450(21)76015, (01)00884838098725(21)76020, (01)00884838098725(21)76021, (01)00884838059450(21)76037, (01)00884838059450(21)76038, (01)00884838059450(21)76040, (01)00884838059450(21)76041, (01)00884838059450(21)76044, (01)00884838059450(21)76046, (01)00884838059450(21)76050, (01)00884838059450(21)76072, (01)00884838059450(21)76076, (01)00884838059450(21)76113, (01)00884838059450(21)76117, (01)00884838059450(21)76122, (01)00884838059450(21)76125, (01)00884838059450(21)76133, (01)00884838059450(21)76134, (01)00884838059450(21)76137, (01)00884838059450(21)76140, (01)00884838059450(21)76182, (01)00884838059450(21)76190, (01)00884838059450(21)76195, (01)00884838059450(21)76199, (01)00884838059450(21)76219, (01)00884838059450(21)76224, (01)00884838059450(21)76236, (01)00884838059450(21)76237, (01)00884838059450(21)76239, (01)00884838059450(21)76255, (01)00884838059450(21)76271, (01)00884838059450(21)76285, (01)00884838059450(21)76290, (01)00884838098725(21)750010, (01)00845225003043(21)750012, (01)00845225003043(21)750017, (01)00884838059450(21)760012, (01)00884838059450(21)760019, (01)00884838059450(21)760021, (01)00884838059450(21)760023, (01)00884838059450(21)760038, (01)00884838059450(21)760045, (01)00884838059450(21)760047, (01)00884838059450(21)760056, (01)00884838059450(21)760064, (01)00884838059450(21)760075, (01)00884838059450(21)760079, (01)00884838059450(21)760081, (01)00845225003043(21)763000, (01)00884838095168, (01)008848380951... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 30, 2025
- Recall initiation date
- Apr 1, 2025
- Center classification date
- Apr 23, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.