FDA Device recall Z-2200-2025
Achieva 3.0T
- FDA Device
- Class II
- ongoing
- Published 2025-08-06
On 2025-08-06 the FDA classified a Class II recall of Achieva 3.0T by Philips North America, citing the potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2200-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-30 |
| Published | 2025-08-06 |
| Last updated | 2026-09-13 11:57 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
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Identifiers
| code_info | Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345; UDI-DI: (1) None, (2) None, (3) 008848…Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345; UDI-DI: (1) None, (2) None, (3) 00884838004139, (4) None, (5) None; Serial Numbers: (1) 17008, 17011, 17017, 17030, 17035, 17038, 17039, 17043, 17049, 17051, 17056, 17061, 17072, 17075, 17079, 17093, 17094, 17099, 17114, 17130, 17134, 17139, 17142, 17144, 17146, 17147, 17149, 17161, 17167, 17168, 17170, 17171, 17178, 17179, 17182, 17183, 17185, 17187, 17189, 17216, 17217, 17226, 17233, 17234, 17235, 17243, 17251, 17256, 17270, 17279, 17295, 17296, 17304, 17316, 17319, 17324, 17334, 17347, 17349, 17358, 17362, 17365, 17374, 17379, 17384, 17392, 17393, 17393, 17402, 17404, 17414, 17418, 17426, 17427, 17431, 17432, 17443, 17445, 17446, 17448, 17450, 17452, 17453, 17456, 17469, 17471, 17494, 17497, 17500, 17523, 17535, 17558, 17561, 17596, 17599, 17607, 24007, 24009, 24010, 24019, 24037, 24038, 24049, 24050, 24053, 24056, 24059, 24060, 24066, 24068, 24070, 24078, 24079, 24081, 24089, 24091, 24096, 24097, 24099 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2200-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.