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

LightSpeed Plus (4-slice MDAS LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron — recall Z-1052-2016

U.S. FDA — Device Enforcement · United States · 2016-02-10 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1052-2016
Date of alert: 2016-02-10
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: GE Medical Systems, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 0850450029

Reported risk: GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.

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

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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