United StatesWhat's 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);
Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;
Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;
Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782117 (3.0T), 4. 782143 (3.0T);
Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1.5T), 3. 781396(1.5T), 4. 782101(1.5T), 5. 782115(1.5T), 6. 782140(1.5T), 7. 781261(1.5T CX), 8. 781262(1.5T CX), 9. 781347(1.5T S);
Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 781356 (X), 5. 782109 (X), 6. 782138 (X);
Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0T CX);
Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5. 782107(X), 6. 782119(X), 7. 782136(X), 8. 782158(X);
Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova (781172), 5. Intera 1.5T Achieva Nova-Dual (781173), 6. Intera 1.5T Omni/Stellar (781104), 7. Intera Achieva 1.5T Pulsar (781171);
MR 5300 Model Number (REF): 1. 782110, 2. 782152;
MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade);
SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X; Model Numbers (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 782146 (1.5T), 4. 782145 (3.0T), 5. 781270 (XR and 3.0T), 6. 782113 (XR and 3.0T), 7. 782129 (XR and 3.0T), 8. 782118 (Ingenia Elition X), 9. 782144 (Ingenia Elition X);
Recalling firm: Philips North America Llc, Cambridge, MA, United States.
How to identify it
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…
The hazard
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
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
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;
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)