FDA Device recall Z-1096-2017
Hitachi Oasis MRI System - C-Spine Coil
- FDA Device
- Class II
- terminated
- Published 2017-02-01
On 2017-02-01 the FDA classified a Class II recall of Hitachi Oasis MRI System - C-Spine Coil by Hitachi Medical Systems America, citing the customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1096-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-06 |
| Published | 2017-02-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Hitachi Medical Systems America |
| Distribution | US |
Product
Hitachi Oasis MRI System - C-Spine Coil
Reason
The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam.
Identifiers
| code_info | M001 to M028, M029 to M083, M085 to M090, M092 to M104, M106, M110 to M111, M113 to M114, M116 to M123, M125, M128 to…M001 to M028, M029 to M083, M085 to M090, M092 to M104, M106, M110 to M111, M113 to M114, M116 to M123, M125, M128 to M131, M133, M139 to M141, M143 to M147, M150, M152, M154, M159, M161, M163, M166, M169 to M176, M179, M182, M183, M185, M186, M190, M194 to 196, M201, M207 to M238 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1096-2017%22
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