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Open, Classified

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 their specifications, are provided in the user documentation. The System generates diagnostic The components may be combined in different configurations to meet specific customer needs. In addition, upgrade configurations are available for predicate devices. The optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. This 510(k) is to incorporate the VolumeRad advanced application that was currently available on the Discovery XR656 product onto the Discovery XR656 HD, as well as introduce a new Metal Artifact Reduction Algorithm, and an optional standalone console to take any HelixTM acquired images via DICOM (such as from a Discovery XR656 HD, Optima XR646 HD, or Optima XR240amx) and process the images independently of the system it was acquired on.

FDA Recall Z-0553-2024 · Posted 2023-12-14

Recalling FirmGE Hangwei Medical Systems, Co. LTD
Recall StatusOpen, Classified
Product CodeKPR
Date Initiated2023-11-07
Product Quantity68 units

Reason for Recall

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.

Firm Action

GE HealthCare issued an URGENT MEDICAL DEVICE CORRECTION to its consignees on 11/07/2023 via FedEx. The notice explained the issue, hazard, and recommended the use of alternative device for patient exams until a service appointment can be scheduled to address the issue. Questions or concerns: Contact 1-800-467-1171 or local Service Representative

Root Cause

Process design

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K191699Discovery XR656 HD with VolumeRadGe Hualun Medical Systems Co. , Ltd. · 2019-07-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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