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

Recall Z-1604-2018 — 708033 URODiagnost As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

U.S. FDA — Device Enforcement · Netherlands · 2018-03-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1604-2018
Date of alert: 2018-03-26
Country / jurisdiction: Netherlands
Risk level: Class II
Risk type: recall
Brand: Philips Medical Systems Nederlands
Product category: device
Product type: Devices

Reported risk: The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot be stopped by the user.

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.

Recall Z-1604-2018 — 708033 URODiagnost As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

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