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

Recall Z-0135-2016 — All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software. Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremitie

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-0135-2016
Date of alert: 2014-05-05
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Philips Medical Systems, Inc.
Product category: device
Product type: Devices

Reported risk: In spine clinical workflows, cross reference lines may be used to determine the position of slices. In cases, where MobiView fused Images are used to show the cross reference lines, the cross reference lines may be positioned incorrectly.

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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