Drug recall
IMRIS ORT100 Table, Part Numbers: (a) 110470-000 (b) 110470-600
FDA recall event 79488 · Class II · Deerfield Imaging, Inc.
Key facts
| Event ID | 79488 |
|---|---|
| Recall numbers | Z-1263-2018, Z-1264-2018, Z-1265-2018, Z-1266-2018 |
| Recalling firm | Deerfield Imaging, Inc. |
| Product type | Devices |
| Products | IMRIS ORT100 Table, Part Numbers: (a) 110470-000 (b) 110470-600, IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114148-000 (d) 114148-600, IMRIS ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 (b) 114093-600, IMRIS T2X Table, Part Numbers: (a) 108000-000 (b) 108000-600 (c) 109682-000 (d) 109682-600 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table. |
| Initiation date | Feb 23, 2018 |
| Report date | Apr 4, 2018 |
| Termination date | Sep 12, 2019 |
| City | Minnetonka |
| State | MN |
| Country | United States |
| FEI number | 3010326005 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: