FDA Device recall Z-0807-2024
Achieva 1.5T, Model No. 781178, 781196, 781296
- FDA Device
- Class III
- ongoing
- Published 2024-01-31
On 2024-01-31 the FDA classified a Class III recall of Achieva 1.5T, Model No. 781178, 781196, 781296 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-0807-2024 |
| 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
Achieva 1.5T, Model No. 781178, 781196, 781296
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. 781178 UDI-DI N/A Serial Number 20150; Model No. 781196 UDI-DI N/A Serial Nos. 22270 22095 21113; Model No…Model No. 781178 UDI-DI N/A Serial Number 20150; Model No. 781196 UDI-DI N/A Serial Nos. 22270 22095 21113; Model No. 781296 UDI-DI 00884838004108 Serial Nos. 33406 33547 32773 32789 32388 |
|---|
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-0807-2024%22
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