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

Recall Z-0809-2015 — Biograph mCT X-4R, System Material Number 10248670. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

U.S. FDA — Device Enforcement · United States · 2014-11-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0809-2015
Date of alert: 2014-11-13
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Siemens Medical Solutions USA Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10248670

Reported risk: Possibility for system display freeze during CT interventional procedures.

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-0809-2015 — Biograph mCT X-4R, System Material Number 10248670. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

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