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

Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 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 determini — recall Z-1425-2017

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-1425-2017
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): 10249556

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

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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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