Drug recall
Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information…
FDA recall event 68262 · Class II · Philips Healthcare Informatics, Inc.
Key facts
| Event ID | 68262 |
|---|---|
| Recall numbers | Z-1646-2014 |
| Recalling firm | Philips Healthcare Informatics, Inc. |
| Product type | Devices |
| Products | Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | When using XIRIS Rio version (8.1.50.0) in conjuncture with iSite PACS a synchronization error can occur and if not noticed, information for the incorrect patient may be displayed |
| Initiation date | May 5, 2014 |
| Report date | May 28, 2014 |
| Termination date | Apr 28, 2015 |
| City | Foster City |
| State | CA |
| Country | United States |
| FEI number | 3002971142 |
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: