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

Recall Z-0553-2024 — The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD system, including thei

U.S. FDA — Device Enforcement · China · 2023-11-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0553-2024
Date of alert: 2023-11-07
Country / jurisdiction: China
Risk level: Class II
Risk type: recall
Brand: GE Hangwei Medical Systems, Co. LTD
Product category: device
Product type: Devices

Reported risk: GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of the Definium Tempo and Definium Tempo Pro products which may result in a potential fall of elements of the Overhead Tube Suspension (OTS) assembly.

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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