FDA Device 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,…
- 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-0553-2024 |
| 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 01001952781183561122100021DX3SS2200214HLSystem ID 205620DEF1; UDI 01001952781183561122100021DX3SS2200210HLSystem I…UDI 01001952781183561122100021DX3SS2200214HLSystem ID 205620DEF1; UDI 01001952781183561122100021DX3SS2200210HLSystem ID 602ABZSCOTTSTMPO; UDI 01001952780702651122060021DX3SS2200096HLSystem ID 408885TEMP1; UDI 01001952781183561122080021DX3SS2200158HLSystem ID 303827DEF1; UDI 01001952781183561122100021DX3SS2200199HLSystem ID 561514DEF1; UDI 01001952781183561123020021DX3SS2300053HLSystem ID 727300DEF; UDI 01001952780702651122100021DX3SS2200194HLSystem ID 229340DEF; UDI 01001952780702651122090021DX3SS2200173HLSystem ID 770219DEF1; UDI 01001952780702651122090021DX3SS2200177HLSystem ID 770219DEF2; UDI Not AvailableSystem ID 912530OPT; UDI 01001952781183561122110021DX3SS2200243HLSystem ID 404778STKTEM1; UDI 01001952781183561122100021DX3SS2200185HLSystem ID 208265DEF1; UDI 01001952781183561122080021DX3SS2200141HLSystem ID NMNMHTEMP1; UDI 01001952780702651123020021DX3SS2300054HLSystem ID NMNMHTEMP2; UDI 01001952781183561122050021DX3SS2200071HLSystem ID 847842TEMP; UDI 01001952781 |
|---|
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-0553-2024%22
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