CLASS II Device recall · Reported 28 May 2014 · FDA Enforcement Report
Philips Xre, the dictation editor system included recalled
Philips Healthcare Informatics is recalling Philips Xre, the dictation editor system included in the Philips Xiris 1.50 Xiris is a, distributed in Florida, Texas. The recall was initiated on 5 May 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1646-2014
- FDA event ID
- 68262
- Recalling firm
- Philips Healthcare Informatics, Foster City, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 May 2014
- FDA classified
- 21 May 2014
- Reported
- 28 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Medical Software
Timeline
| 5 May 2014 | Recall initiated by company | |
| 21 May 2014 | Classified by FDA | +16 days |
| 28 May 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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, manipulating and retrieving of patient information. This included patient scheduling and tracking and workflow and reporting management.
Where it was distributed
Worldwide Distribution - US including the states of FL and TX and the countries Canada and South Africa.
Questions about this recall
Is Philips Xre, the dictation editor system included in the Philips Xiris 1.50 Xiris is a recalled?
Yes. Philips Healthcare Informatics recalled Philips Xre, the dictation editor system included in the Philips Xiris 1.50 Xiris is a on 5 May 2014. The recall is Class II and its status is Terminated. Recall number Z-1646-2014.
Why was it recalled?
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
Which lots are affected?
Model XIRIS 8.1 version XIRIS 8.1.50.0
Where was it sold?
Worldwide Distribution - US including the states of FL and TX and the countries Canada and South Africa.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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