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OmniWire Pressure guide wire recallZ-1660-2025 · Philips North America Llc · initiated Apr 1, 2025

Open, Classified

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

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

FDA root cause category: Software design

What the company 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: [email protected]. 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.

Recall details

Recall number
Z-1660-2025
Status
Open, Classified
Initiated by the company
Apr 1, 2025
Posted by the FDA
Apr 23, 2025
Recalling firm
Philips North America Llc
Quantity
630 units
Product code
JAK
FDA submissions
K171850
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.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (23k characters)

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(01)00884838095168(21)766027, (01)00884838095168(21)766028, (01)00884838095168(21)766029, (01)00884838095168(21)766030, (01)00884838095168(21)766031, (01)00884838095168(21)766032, (01)00884838095168(21)766033, (01)00884838095168(21)766034, (01)00884838095168(21)766035, (01)00884838095168(21)766036, (01)00884838095168(21)766037, (01)00884838095168(21)766038, (01)00884838095168(21)766039, (01)00884838095168(21)766040, (01)00884838095168(21)766041, (01)00884838095168(21)766042, (01)00884838095168(21)766043, (01)00884838095168(21)766044, (01)00884838095168(21)766045, (01)00884838095168(21)766046, (01)00884838095168(21)766047, (01)00884838095168(21)766048, (01)00884838095168(21)766049, (01)00884838095168(21)766050, (01)00884838095168(21)766051, (01)00884838095168(21)766052, (01)00884838095168(21)766053, (01)00884838095168(21)766054, (01)00884838095168(21)766055, (01)00884838095168(21)766056, (01)00884838095168(21)766057, (01)00884838095168(21)766058, (01)00884838095168(21)766059, (01)00884838095168(21)766060, (01)00884838095168(21)766061, (01)00884838095168(21)766062, (01)00884838095168(21)766063, (01)00884838095168(21)766064, (01)00884838095168(21)766065, (01)00884838095168(21)766066, (01)00884838095168(21)766067, (01)00884838095168(21)766068, (01)00884838095168(21)766069, (01)00884838095168(21)766070, (01)00884838095168(21)766071, (01)00884838095168(21)766072, (01)00884838095168(21)766073, (01)00884838095168(21)766074, (01)00884838095168(21)766075, (01)00884838095168(21)766076, (01)00884838095168(21)766077, (01)00884838095168(21)766078, (01)00884838095168(21)766079, (01)00884838095168(21)766080, (01)00884838095168(21)766081, (01)00884838095168(21)766082, (01)00884838095168(21)766083, (01)00884838095168(21)766084, (01)00884838095168(21)766085, (01)00884838095168(21)766086, (01)00884838095168(21)766087, (01)00884838095168(21)766088, (01)00884838095168(21)766089, (01)00884838095168(21)766090, (01)00884838095168(21)766091, (01)00884838095168(21)766092, (01)00884838095168(21)766093, (01)00884838095168(21)766094, (01)00884838095168(21)766095, (01)00884838095168(21)766096, (01)00884838095168(21)766097, (01)00884838095168(21)766098, (01)00884838095168(21)766099, (01)00884838095168(21)766100, (01)00884838095168(21)766101, (01)00884838095168(21)766102, (01)00884838095168(21)766103, (01)00884838095168(21)766104, (01)00884838095168(21)766105, (01)00884838095168(21)766106, (01)00884838095168(21)766107, (01)00884838095168(21)766108, (01)00884838095168(21)766109, (01)00884838095168(21)766110, (01)00884838095168(21)766111, (01)00884838095168(21)766112, (01)00884838095168(21)766113, (01)00884838095168(21)766114, (01)00884838095168(21)766115, (01)00884838095168(21)766116, (01)00884838095168(21)766117, (01)00884838095168(21)766118, (01)00884838095168(21)766119, (01)00884838095168(21)766120, (01)00884838095168(21)766121, (01)00884838095168(21)766122, (01)00884838095168(21)766123, (01)00884838095168(21)766124, (01)00884838095168(21)766125, (01)00884838095168(21)766126, (01)00884838095168(21)766127, (01)00884838095168(21)766128, (01)00884838095168(21)766129, (01)00884838095168(21)766130, (01)00884838095168(21)766131, (01)00884838095168(21)766132, (01)00884838095168(21)766133, (01)00884838095168(21)766134, (01)00884838095168(21)766135, (01)00884838095168(21)766136, (01)00884838095168(21)766137, (01)00884838095168(21)766138, (01)00884838095168(21)766140, (01)00884838095168(21)766141, (01)00884838095168(21)766142, (01)00884838095168(21)766143, (01)00884838095168(21)766144, (01)00884838095168(21)766145, (01)00884838095168(21)766146, (01)00845225003043(21)768002, (01)00845225003043(21)768003, (01)00884838095168, (01)00884838095168, (01)00884838095168, (01)00884838095168, (01)00884838095168(21)768008, (01)00884838095168(21)768009, (01)00884838095168(21)768010, (01)00884838095168(21)768011, (01)00884838095168(21)768012, (01)00884838095168(21)768013, (01)00884838095168(21)768014, (01)00884838095168(21)768015, (01)00884838095168(21)768016, (01)00884838095168(21)768017, (01)00884838095168(21)768018, (01)00884838095168(21)768019, (01)00884838095168(21)768020, (01)00884838095168(21)768021, (01)00884838095168(21)768022; Serial No. 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.

Devices named in this recall

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

Product lines

Sources and updates

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