Data Foundry

Medical device recalls 2018

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 numberZ-0646-2019
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmDeerfield Imaging, Inc., Minnetonka, MN, United States
Recall initiated2018-11-06
Classified2018-12-20
Reported by FDA2018-12-26
Terminated2021-07-25
DistributedNationwide (US)
Countries outside the USAU, CA, CN, DE, FR, IT, JP, QA, SE
Quantity27 units
Serial numbers10002341, 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 numbers110470-000, 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.