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

Recall Z-1424-2017 — Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining var

U.S. FDA — Device Enforcement · United States · 2017-02-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1424-2017
Date of alert: 2017-02-20
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): 10249555

Reported risk: The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.

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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