Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 8, 2015
GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnostic imaging system for radiographic and fluoroscopic examinations. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Legacy and Legacy D Table is intended for use in a diagnostic X-ray system to support patient during general purpose radiological procedures in the horizontal, vertical and Trendelenburg positions.
The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is installed to hold and prevent the SFD/IDD from falling due to a counte…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ge Healthcare recalled GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Sy… - a moderate-severity action.
GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Sy… was recalled by Ge Healthcare in July 8, 2015. Reason: The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is …. Check the official notice for the remedy. Verify recall #Z-1966-2015 with the FDA Devices before acting.
The recall
Ge Healthcare issued this moderate-severity FDA Devices recall-The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is ….
- Moderate
- severity level
- Class II
- classification
- July 8, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1966-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1966-2015) was formally reported on July 8, 2015, with the manufacturer initiating the action on June 12, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Ge Healthcare is listed as the recalling firm, operating out of Waukesha, WI. Federal records list the affected scope as 4,053 (3,804 US; 249 OUS).
The documented reason for this recall is: The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is installed to hold and prevent the SFD/IDD from falling due to a counterweight cable failure. The lower range o… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide including PR, GU and DC and the countries of: Afghanistan, Argentina, Australia, Austria, Belgium, Bermuda, Canada, Cayman Islands, Chile, Colombia, Czech Republic, Dominican Repub…. 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
4,053 (3,804 US; 249 OUS)
Related Recalls
6
3 from same agency
Product description
GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnostic imaging system for radiographic and fluoroscopic examinations. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Legacy and Legacy D Table is intended for use in a diagnostic X-ray system to support patient during general purpose radiological procedures in the horizontal, vertical and Trendelenburg positions.
Reason for recall
The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is installed to hold and prevent the SFD/IDD from falling due to a counterweight cable failure. The lower range of travel is 1.1 in (28mm) from the lowest point of normal SFD/IDD vertical compression. A fall of the SFD/IDD could result in an injury to a patient or operator.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1966-2015 |
| Date reported | July 8, 2015 |
| Date initiated | June 12, 2015 |
| Recalling firm | Ge Healthcare |
| Firm location | Waukesha, WI |
| Affected scope | 4,053 (3,804 US; 249 OUS) |
| Distribution | Worldwide Distribution - US Nationwide including PR, GU and DC and the countries of: Afghanistan, Argentina, Australia, Austria, Belgium, Bermuda, Canada, Cayman Islands, Chile, Colombia, Czech Republic, Dominican Republic, Ecuador, Egypt,… |
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-1966-2015) 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? ▼
GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnostic imaging system for radiographic and fluoroscopic examinations. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Legacy and Legacy D Table is intended for use in a diagnostic X-ray system to support patient during general purpose radiological procedures in the horizontal, vertical and Trendelenburg positions.. Recalled by Ge Healthcare. Units affected: 4,053 (3,804 US; 249 OUS).
Why was this product recalled? ▼
The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is installed to hold and prevent the SFD/IDD from falling due to a counterweight cable failure. The lower range of travel is 1.1 in (28mm) from the lowest point of normal SFD/IDD vertical compression. A fall of the SFD/IDD could result in an injury to a patient or operator.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 8, 2015. Severity: Moderate. Recall number: Z-1966-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide including PR, GU and DC and the countries of: Afghanistan, Argentina, Australia, Austria, Belgium, Bermuda, Canada, Cayman Islands, Chile, Colombia, Czech Republic, Dominican Republic, Ecuador, Egypt, France, Germany, Ghana, Guatemala, Honduras, Indonesia, Ireland, Israel, Italy, Jamaica, Jordan, Korea (Republic of), Kuwait, Libyan Arab Jamahiriya, Malaysia, Malta, Mexico, New Zealand, Panama, Romania, Russia, Saudi Arabia, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Vietnam, and Yemen..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1966-2015) 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 July 8, 2015. 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.