Imactis CT-Navigation System — Class II medical device recall Z-1590-2026
Ongoing recall by GE Medical Systems, LLC, reported 2026-04-01, distributed nationwide. There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position a
| Recall number | Z-1590-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems, LLC, Waukesha, WI, United States |
| Recall initiated | 2026-02-03 |
| Classified | 2026-03-20 |
| Reported by FDA | 2026-04-01 |
| Distributed | Nationwide (US) |
| Quantity | 125 units |
| Model numbers | E85101LA, E85101LP |
Product
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
Reason for recall
There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.
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-1590-2026. 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.