FDA Device recall Z-1436-2018
Conversion SmarthPath to dStream for 1.5T, Model 781260 Product Usage: Indicated for use as a diagnostic device
- FDA Device
- Class II
- terminated
- Published 2018-04-25
On 2018-04-25 the FDA classified a Class II recall of Conversion SmarthPath to dStream for 1.5T, Model 781260 Product Usage: Indicated for use as a diagnostic device by Philips Electronics North America, citing potential risk for helium gas inside the MR examination room during a magnet quench.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1436-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-16 |
| Published | 2018-04-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Electronics North America |
| Distribution | US |
Product
Conversion SmarthPath to dStream for 1.5T, Model 781260 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Reason
Potential risk for helium gas inside the MR examination room during a magnet quench
Identifiers
| code_info | (Added 6/25/18): 39005 20071 18673 8715 8971 8165 8996 39024 10077 18528 32174 8578 10058 21290 10703 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1436-2018%22
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