Drug recall
Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For…
FDA recall event 68298 · Class II · Hologic, Inc.
Key facts
| Event ID | 68298 |
|---|---|
| Recall numbers | Z-1700-2014, Z-1701-2014 |
| Recalling firm | Hologic, Inc. |
| Product type | Devices |
| Products | Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast., Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury |
| Initiation date | May 13, 2014 |
| Report date | Jun 11, 2014 |
| Termination date | Aug 18, 2014 |
| City | Danbury |
| State | CT |
| Country | United States |
| FEI number | 1220984 |
At a glance
- 1–9 Products in this recall
- 10–99 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: