FDAFDA recall Z-3232-2026 · Sep 30, 2026

Philips North America Llc: Achieva 1 recall

Recall found

Product

Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2. 781343 (Achieva 1.5T), 3. 781283 (Achieva 1.5T Conversion), 4. 781346 (Achieva 1.5 Conversion), 5. 781178 (Achieva 1.5T Initial System);

Reason for recall

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

What to do

FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.

Recall details

FDA classification: Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Status: Ongoing
Codes, lots and dates: 1. Model Numbers (REF): 781196 (Achieva 1.5T); UDI-DI: N/A; Serial Numbers: 22135, 21807, 22149, 22162, 22186, 22264, 21329, 21787, 21989, 22022, 22150, 22180, 22270, 21674, 22080, 21190, 21254, 21315, 21530, 21592, 21903, 21913, 21914, 22072, 22076, 22161, 22176, 22217, 22278, 21796, 21996, 21306, 21499, 21525, 21556, 21626, 21897, 21985, 22213, 22056, 21342, 21571, 21594, 21810, 21924, 22335, 21235, 21492, 22198, 21243, 21449, 22029, 22069, 21731, 22095, 22185, 22239, 22108, 22079, 21984, 21073, 21211, 21269, 21487, 21488, 21550, 21598, 21624, 21808, 22071, 22223, 21911, 21225, 21954, 21215, 21397, 21431, 21689, 21986, 22021, 22243, 21427, 22117, 22326, 21076, 21104, 21183, 21264, 21272, 21284, 21321, 21334, 21351, 21405, 21455, 21479, 21494, 21508, 21572, 21574, 21589, 21666, 21776, 21805, 21868, 21879, 21935, 21957, 21968, 21993, 22001, 22004, 22066, 22130, 22136, 22155, 22207, 22258; 2. Model Numbers (REF): 781343 (Achieva 1.5T); UDI-DI: 884838055292; Serial Numbers: 72020, 72104, 72137, 72138, 72146, 72157, 72160, 72170, 72171, 72179, 72183, 72185, 72200, 72223, 72233, 72238, 72251, 72269, 72013, 72111, 72113, 72231, 72235, 72270, 72271, 72273, 72286, 72079, 72083, 72109, 72120, 72122, 72123, 72124, 72126, 72139, 72141, 72142, 72147, 72150, 72247, 72007, 72156, 72101, 72116, 72117, 72180, 72197, 72267, 72189, 72008, 72080, 72036, 72052, 72057, 72103, 72134, 72143, 72144, 72145, 72151, 72186, 72199, 72217, 72224, 72227, 72228, 72236, 72253, 72254, 72255, 72256, 72257, 72258, 72259, 72260, 72264, 72278, 72279, 72296, 72297, 72298, 72299, 72304, 72029, 72129, 72153, 72175, 72194, 72207, 72281, 72290, 72301, 72302, 72310, 72311, 72316, 72320, 72321, 72326, 72329, 72075, 72076, 72261, 72022, 72047, 72100, 72154, 72159, 72240, 72285, 72287, 72317, 72324, 72015, 72016, 72023, 72071, 72074, 72205, 72038, 72322, 72053, 72063, 72077, 72118, 72121, 72177, 72188, 72192, 72202, 72203, 72265, 72274, 72288, 72289, 72308, 72313, 72048, 72001, 72058, 72230, 72234, 72102, 72201, 72003, 72040, 72114, 72010, 72049, 72055, 72136, 72148, 72266, 72319, 72222, 72034, 72198, 72220, 72226, 72119, 72168, 72303, 72309, 72312, 72318, 72025, 72066, 72193, 72325, 72327, 72331, 72174, 72082, 72249; 3. Model Numbers (REF): 781283 (Achieva 1.5T Conversion); UDI-DI: N/A; Serial Numbers: 39056, 8989, 10126, 39098, 39108, 39004, 39010, 39028, 39032, 39086, 39094, 39095, 39058, 39091, 39105, 39053, 39073, 39067, 39016, 39025; 4. Model Numbers (REF): 781346 (Achieva 1.5 Conversion); UDI-DI: N/A; Serial Numbers: 18052, 8361, 8415, 10015, 75008, 5243, 8727, 10172, 10189, 10545, 18737, 75002, 75003, 75004, 75015, 8059, 8757, 8767, 8842, 8883, 8886, 8897, 8946, 8974, 8981, 8990, 10060, 18001, 18710, 75009, 75092, 75095, 75099, 75100, 8069, 8312, 8520, 10006, 10048, 18588, 75000, 75001, 75005, 75031, 75049, 75087, 8371, 8289, 8367, 8740, 10539, 75011, 8351, 8782, 8756, 75010, 75007, 8124, 8020; 5. Model Numbers (REF): 781178 (Achieva 1.5T Initial System); UDI-DI: N/A; Serial Numbers: 20095, 20056, 20230, 20258, 20085, 20094, 20113, 20050, 20072, 20088, 20096, 20252, 20281, 20297, 20307;
Quantity: 387
Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia;
Recalling firm: Philips North America Llc, Cambridge, MA
Voluntary or mandated: Voluntary: Firm initiated
Recall started: 2026-08-21

Source: openFDA enforcement record Z-3232-2026 · search recall number Z-3232-2026 in FDA's Enforcement Report.

Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.