Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1646-2014 — 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 wor

U.S. FDA — Device Enforcement · United States · 2014-05-05 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1646-2014
Date of alert: 2014-05-05
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Philips Healthcare Informatics, Inc.
Product category: device
Product type: Devices

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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