FDA Device recall Z-3233-2026
Achieva 3.0T
- FDA Device
- Class II
- ongoing
- Published 2026-09-30
On 2026-09-30 the FDA classified a Class II recall of Achieva 3.0T by Philips North America, citing A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3233-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-21 |
| Published | 2026-09-30 |
| Last updated | 2026-10-06 05:30 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;
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.
Identifiers
| code_info | 1. Model Numbers (REF): 781177; UDI-DI: N/A; Serial Numbers: 17144, 17376, 17448, 24049, 17099, 24138, 24060, 17607, 17…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, 384 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-06 05:30 UTC. Current status: ongoing.
Other recalls by Philips North America
- Ingenia 3.0T and 3.0T CX
FDA Device · Class II · 2026-10-07 · Philips North America - MR 7700
FDA Device · Class II · 2026-10-07 · Philips North America - SmartPath to MR 7700
FDA Device · Class II · 2026-10-07 · Philips North America - Upgrade to MR 7700
FDA Device · Class II · 2026-10-07 · Philips North America - Upgrade dStream
FDA Device · Class II · 2026-10-07 · Philips North America
All Philips North America recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3233-2026%22
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