Philips XIRIS 8.1.50.0 Recall Due to Patient Data Synchronization Error
Philips Healthcare Informatics is recalling 5 units of XIRIS 8.1.50.0 due to a synchronization error that may display incorrect patient information.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential patient safety risks without confirmed harm.
Plain-English summary
Philips Healthcare Informatics, Inc. is recalling 5 units of the Philips XIRIS 8.1.50.0 radiology information system (RIS). The recall involves the XRE dictation editor system included in the software. The affected units were distributed worldwide, including in the United States (Florida and Texas), Canada, and South Africa.
The recall is due to a synchronization error that can occur when using XIRIS Rio version 8.1.50.0 in conjunction with iSite PACS. If this error is not noticed, information for the incorrect patient may be displayed. This poses a risk of patient safety issues due to the potential for misidentification of patient data.
Healthcare facilities using this specific version of the software should contact Philips Healthcare Informatics for further instructions on how to resolve the synchronization issue.
The recalled product
- Product
- 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…
- Manufacturer
- Philips Healthcare Informatics, Inc.
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model XIRIS 8.1 version XIRIS 8.1.50.0
Distribution
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