Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;
Summary
The FDA issued a Class II for Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, by Philips North America Llc. Reason: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstr.
Details
Source
Device Recall
External ID
Z-3233-2026
Action Date
2026-09-30
Status
Ongoing
Category
device
Product Description
Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;
Lot/Code Info: 1. Model Numbers (REF): 781177; UDI-DI: N/A; Serial Numbers: 17144, 17376, 17448, 24049, 17099, 24138, 24060, 17607, 17079, 17146, 17189, 17379, 17469, 17270, 17432, 17279, 17233, 17295, 17446, 17362, 24068, 24096, 17139, 24037, 24099, 17535, 24079, 17030, 17043, 17056, 17114, 17149, 17161, 17167, 17170, 17179, 17216, 17217, 17235, 17251, 17316, 17319, 17365, 17453, 17494, 17523, 17558, 17561, 24038, 24070, 24089; 2. Model Numbers (REF): 781277; UDI-DI: N/A; Serial Numbers: 34289, 34213, 34276, 34113, 34123, 34239, 34264, 34274, 34285, 34095, 34138, 34305, 34118, 34106, 34159, 34241, 34263, 34139, 34002, 34029, 34034, 34071, 34201; 3. Model Numbers (REF): 781278; UDI-DI: N/A; Serial Numbers: 38326, 38346, 38043, 38098, 38108, 38152, 38157, 38194, 38210, 38212, 38215, 38231, 38233, 38236, 38238, 38240, 38267, 38269, 38270, 38271, 38284, 38312, 38321, 38328, 38332, 38338, 38339, 38340, 38344, 38349, 38367, 38370, 38401, 38402, 38405, 38407, 38408, 38412, 38415, 38420, 38421, 38423, 38425, 38426, 38427, 38430, 38431, 38432, 38433, 38437, 38439, 38441, 38442, 38443, 38445, 38447, 38448, 38450, 38453, 38454, 38456, 38457, 38458, 38288, 38079, 38139, 38228, 38145, 38034, 38251, 38278, 38207, 38061, 38086, 38095, 38115, 38133, 38017, 38064, 38112, 38143, 38160, 38183, 38229, 38256, 38296, 38297, 38315, 38331, 38272, 38322, 38323, 38337, 38345, 38077, 38200, 38268, 38090, 38188, 38093, 38012, 38099, 38003, 38057, 38072, 38085, 38016, 38033, 38091, 38103, 38173, 38341, 38232; 4. Model Numbers (REF): 781344; UDI-DI: N/A; Serial Numbers: 73005, 73008, 73009, 73006, 73010; 5. Model Numbers (REF): 781345; UDI-DI: N/A; Serial Numbers: 74027, 74035, 74039, 74047, 74052, 74001, 74010, 74026, 74046, 74005, 74007, 74021, 74030, 74040, 74044, 74048, 74032, 74037;
Quantity Affected: 210
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.
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;
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-21
Company
Cambridge, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 196 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Philips North America Llc has 283 FDA actions in our database, including 283 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips North America Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips North America Llc have FDA actions?
Philips North America Llc has 283 FDA actions in our database, including 283 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3233-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29