Drug recall
Big Bore Oncology tomography X-ray system scanner, model number 728243. The Big Bore Oncology scanner is a…
FDA recall event 74507 · Class II · Philips Medical Systems (Cleveland) Inc
Key facts
| Event ID | 74507 |
|---|---|
| Recall numbers | Z-2109-2016, Z-2110-2016 |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Product type | Devices |
| Products | Big Bore Oncology tomography X-ray system scanner, model number 728243. The Big Bore Oncology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the…, Big Bore Radiology tomography X-ray system scanner, model number 728244. The Big Bore Radiology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Socket Head Cap Screws (SHCS) used in the Z-Axis Adjustment Plate were found to be made of stainless steel rather than the specified alloy steel. |
| Initiation date | Jun 14, 2016 |
| Report date | Jul 6, 2016 |
| Termination date | Jul 2, 2018 |
| City | Cleveland |
| State | OH |
| Country | United States |
| FEI number | 1525965 |
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: