Drug recall
Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System
FDA recall event 91959 · Class II · NeuroLogica Corporation
Key facts
| Event ID | 91959 |
|---|---|
| Recall numbers | Z-1414-2023 |
| Recalling firm | NeuroLogica Corporation |
| Product type | Devices |
| Products | Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm due to a fall of the arm |
| Initiation date | Mar 8, 2023 |
| Report date | Apr 26, 2023 |
| City | Danvers |
| State | MA |
| Country | United States |
| FEI number | 3004938766 |
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: