Achieva XR; Model Numbers (REF) recall
Philips North America Llc recalled Achieva XR; Model Numbers (REF) on September 30, 2026 because of 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. It was sold nationwide.
Why it was recalled
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's recalled
Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;
Quantity: 15
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Philips North America Llc, Cambridge, MA
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
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… - Status
- Ongoing
- Recall number
- Z-3234-2026
- Source
- U.S. Food and Drug Administration
More medical devices recalls
· Olympus Corporation of the AmericasMedline convenience kits containing Healthmark Instrument Channel Brushes
· Medline Industries, LPMidmark IQvitals Zone
· Midmark CorporationAchieva 3.0T; Model Numbers (REF)
· Philips North America LlcAutomated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1
· Abiomed, Inc.INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set
· CooperSurgical, Inc.