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

Recall Z-2236-2012 — OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a ref

U.S. FDA — Device Enforcement · United States · 2006-10-11 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2236-2012
Date of alert: 2006-10-11
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: GE OEC Medical Systems, Inc
Product category: device
Product type: Devices

Reported risk: GE Healthcare had recalled certain OEC InstaTrak 3500 Carts due to the potential for the cart to tip over when the arm of the imaging device is extended during use.

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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