FDA Device recall Z-0552-2024
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table,…
- FDA Device
- Class II
- ongoing
- Published 2023-12-20
On 2023-12-20 the FDA classified a Class II recall of The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table,… by Ge Hangwei Medical Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0552-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-07 |
| Published | 2023-12-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Hangwei Medical Systems |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | UDI 01001952781183561122100021DX3SS2200214HL, System ID 205620DEF1; UDI 01001952781183561122080021DX3SS2200165HL, Syste…UDI 01001952781183561122100021DX3SS2200214HL, System ID 205620DEF1; UDI 01001952781183561122080021DX3SS2200165HL, System ID 205783DEF1; UDI 01001952781183561122100021DX3SS2200211HL, System ID 205387DEF1; UDI 01001952781183561122110021DX3SS2200216HL, System ID 623ABZARRWTMPO; UDI 01001952781183561122120021DX3SS2300001HL, System ID 928263DEF1; UDI 01001952781183561123040021DX3SS2300103HL, System ID 520NOGTEMPO; UDI 01001952781183561122100021DX3SS2200210HL, System ID 602ABZSCOTTSTMPO; UDI 01001952781183561122110021DX3SS2200223HL, System ID 602ABZCNTRLTMPO; UDI 01001952781183561123030021DX3SS2300082HL, System ID 209324DEF1; UDI 01001952781183561123020021DX3SS2300046HL, System ID 209497DEF1; UDI 01001952781183561122080021DX3SS2200158HL, System ID 303827DEF1; UDI 01001952781183561123010021DX3SS2300030HL, System ID 970242DEF1; UDI 01001952781183561122080021DX3SS2200168HL, System ID 303457DEF1; UDI 01001952781183561122030021DX3SS2200047HL, System ID 860545TEMPO1; UDI 01001952781183561122030021 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0552-2024%22
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