Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported December 20, 2023
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, upgr
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ge Hangwei Medical Systems, Co. LTD recalled The System is designed as a modular system with components that include an Overhead Tube … - a moderate-severity action.
The System is designed as a modular system with components that include an Overhead Tube … was recalled by Ge Hangwei Medical Systems, Co. LTD in December 20, 2023. Reason: GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of th…. Check the official notice for the remedy. Verify recall #Z-0552-2024 with the FDA Devices before acting.
The recall
Ge Hangwei Medical Systems, Co. LTD issued this moderate-severity FDA Devices recall-GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of th….
- Moderate
- severity level
- 134 units
- affected scope
- Class II
- classification
- December 20, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0552-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0552-2024) was formally reported on December 20, 2023, with the manufacturer initiating the action on November 7, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Ge Hangwei Medical Systems, Co. LTD is listed as the recalling firm, operating out of Beijing, N/A. Federal records list the affected scope as 134 units.
The documented reason for this recall is: 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 Overh… Distribution data in the federal record shows the product reached: US Nationwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
134 units
Related Recalls
6
3 from same agency
Product description
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 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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0552-2024 |
| Date reported | December 20, 2023 |
| Date initiated | November 7, 2023 |
| Recalling firm | Ge Hangwei Medical Systems, Co. LTD |
| Firm location | Beijing, N/A |
| Affected scope | 134 units |
| Distribution | US Nationwide distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0552-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ge Hangwei Medical Systems, Co. LTD. Units affected: 134 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 20, 2023. Severity: Moderate. Recall number: Z-0552-2024.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0552-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 20, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.