FDA Device recall Z-0812-2024
SmartPath to dStream for 1.5T, Model No. 781260, 782112
- FDA Device
- Class III
- ongoing
- Published 2024-01-31
On 2024-01-31 the FDA classified a Class III recall of SmartPath to dStream for 1.5T, Model No. 781260, 782112 by Philips North America, citing an incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0812-2024 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2023-12-29 |
| Published | 2024-01-31 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips North America |
| Distribution | US |
Product
SmartPath to dStream for 1.5T, Model No. 781260, 782112
Reason
An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.
Identifiers
| code_info | Model No. 781260 UDI-DI 00884838095076 Serial Numbers 21020 9024 8657 21200 21223 18948 32131; Model No. 782112 UDI-DI…Model No. 781260 UDI-DI 00884838095076 Serial Numbers 21020 9024 8657 21200 21223 18948 32131; Model No. 782112 UDI-DI 00884838098886 Serial Numbers 30089 20204 |
|---|
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-0812-2024%22
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