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

Recall Z-1997-2016 — BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 Product Usage: 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 · 2016-04-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1997-2016
Date of alert: 2016-04-25
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): 10507786

Reported risk: The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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