Achieva 1.5T recall (Philips North America Llc)
Medical deviceClass IIOngoing
Summary: Philips North America Llc is recalling 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: 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 is being recalled
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);
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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; (states named: Georgia)
How to tell if yours is affected
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;
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3232-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 21, 2026 |
| Reported | September 30, 2026 |
| Company | Philips North America Llc |
| Company location | Cambridge, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 387 |
More recalls from Philips North America Llc · all medical device recalls · recalls from August 2026