Achieva 3 — Class III medical device recall Z-0809-2024
Ongoing recall by Philips North America, reported 2024-01-31, distributed nationwide. An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affect
| Recall number | Z-0809-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, Cambridge, MA, United States |
| Recall initiated | 2023-12-29 |
| Classified | 2024-01-25 |
| Reported by FDA | 2024-01-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, CN, DE, GR, IN, MX, SA |
| Reason classes | labeling |
| Serial numbers | 17043 |
| Model numbers | 781177 |
Product
Achieva 3.0T, Model No. 781177
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0809-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.