Drug recall
Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004…
FDA recall event 80400 · Class II · Philips Medical Systems (Cleveland) Inc
Key facts
| Event ID | 80400 |
|---|---|
| Recall numbers | Z-2496-2018 |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Product type | Devices |
| Products | Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01)00884838059559(21)900006 (01)00884838059559(21)900007… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The block used to connect the patient pallet to the couch may be assembled incorrectly. A screw may be misaligned in the patient pallet. |
| Initiation date | May 21, 2018 |
| Report date | Jul 25, 2018 |
| Termination date | Apr 10, 2020 |
| 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: