IMRIS ORT 100 table — Class II medical device recall Z-0646-2019
Terminated recall by Deerfield Imaging, Inc., reported 2018-12-26, distributed nationwide. Table may drift in the roll position while in use
| Recall number | Z-0646-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Deerfield Imaging, Inc., Minnetonka, MN, United States |
| Recall initiated | 2018-11-06 |
| Classified | 2018-12-20 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2021-07-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CN, DE, FR, IT, JP, QA, SE |
| Quantity | 27 units |
| Serial numbers | 10002341, 10002343, 10002607, 10002654, 10002796, 10002845, 10002847, 10002848, 10003007, 10003064, 10003241, 10003243, 10003244, 10003245, 10003629, 10003801, 10003830, 10003841, 10004250, 10004439, 10004576, 10005651, 10006438, 10006886, 10007348 and 1 more |
| Model numbers | 110470-000, 110470-600 |
Product
IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.
Reason for recall
Table may drift in the roll position while in use
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-0646-2019. 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.