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

Recall Z-0584-2014 — Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a multifunctional stationary X-ray system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are motorized. It is designed for radiographic examination of t

U.S. FDA — Device Enforcement · United States · 2013-12-05 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0584-2014
Date of alert: 2013-12-05
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Philips Medical Systems, Inc.
Product category: device
Product type: Devices

Reported risk: X-ray system C-arm casting may loosen and fall

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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