Aperio ScanScope System — Class II medical device recall Z-1549-2013
Terminated recall by Aperio Technologies Inc, reported 2013-06-26, distributed nationwide. Aperio initiated this recall because the User Guides incorrectly state the devices had been cleared for specif
| Recall number | Z-1549-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aperio Technologies Inc, Vista, CA, United States |
| Recall initiated | 2013-02-22 |
| Classified | 2013-06-17 |
| Reported by FDA | 2013-06-26 |
| Terminated | 2013-09-25 |
| Distributed | Nationwide (US) |
| Quantity | 364 |
Product
Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide creation and viewing device. It is intended to create and view electronic image files representative of tissue specimens fixed to glass slides.
Reason for recall
Aperio initiated this recall because the User Guides incorrectly state the devices had been cleared for specific applications. The User Guides should state the devices are for Research Use Only and are not for use in diagnostic procedures.
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-1549-2013. 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.