Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 12, 2014
GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole bo
GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D, Precision MPI & Precision RXI X-ray imaging systems overhead LCD Video Monitor Su…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ge Healthcare, LLC recalled GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The… - a moderate-severity action.
GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The… was recalled by Ge Healthcare, LLC in February 12, 2014. Reason: GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D, Precision M…. Check the official notice for the remedy. Verify recall #Z-0911-2014 with the FDA Devices before acting.
The recall
Ge Healthcare, LLC issued this moderate-severity FDA Devices recall-GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D, Precision M….
- Moderate
- severity level
- Class II
- classification
- February 12, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0911-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0911-2014) was formally reported on February 12, 2014, with the manufacturer initiating the action on December 12, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Ge Healthcare, LLC is listed as the recalling firm, operating out of Waukesha, WI. Federal records list the affected scope as 816 (722 US, 94 OUS)..
The documented reason for this recall is: GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D, Precision MPI & Precision RXI X-ray imaging systems overhead LCD Video Monitor Suspension (Single monitor & Dual monitor)… Distribution data in the federal record shows the product reached: Worldwide distribution: US (nationwide) including Guam and DC but excluding CT, DE, HI and RI; and internationally to: AUSTRALIA, BULGARIA, CANADA, CHILE, DOMINICAN REPUBLIC, GERMANY, HONDURAS, IRELAND, ITALY, KUWAIT, L…. 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
816 (722 US, 94 OUS).
Related Recalls
6
3 from same agency
Product description
GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Reason for recall
GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D, Precision MPI & Precision RXI X-ray imaging systems overhead LCD Video Monitor Suspension (Single monitor & Dual monitor). There is a potential for the locking nut to loosen out of the LCD Video Monitor Suspension yoke. This will not lead to an immediate fall of the suspended monitor since it will
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0911-2014 |
| Date reported | February 12, 2014 |
| Date initiated | December 12, 2013 |
| Recalling firm | Ge Healthcare, LLC |
| Firm location | Waukesha, WI |
| Affected scope | 816 (722 US, 94 OUS). |
| Distribution | Worldwide distribution: US (nationwide) including Guam and DC but excluding CT, DE, HI and RI; and internationally to: AUSTRALIA, BULGARIA, CANADA, CHILE, DOMINICAN REPUBLIC, GERMANY, HONDURAS, IRELAND, ITALY, KUWAIT, LEBANON, MALTA, NAMIB… |
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-0911-2014) 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, Precision MPI & Precision RXI X-ray imaging systems. The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.. Recalled by Ge Healthcare, LLC. Units affected: 816 (722 US, 94 OUS)..
Why was this product recalled? ▼
GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D, Precision MPI & Precision RXI X-ray imaging systems overhead LCD Video Monitor Suspension (Single monitor & Dual monitor). There is a potential for the locking nut to loosen out of the LCD Video Monitor Suspension yoke. This will not lead to an immediate fall of the suspended monitor since it will
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 12, 2014. Severity: Moderate. Recall number: Z-0911-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: US (nationwide) including Guam and DC but excluding CT, DE, HI and RI; and internationally to: AUSTRALIA, BULGARIA, CANADA, CHILE, DOMINICAN REPUBLIC, GERMANY, HONDURAS, IRELAND, ITALY, KUWAIT, LEBANON, MALTA, NAMIBIA, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SLOVAKIA, SPAIN, SWITZERLAND, TAIWAN, TURKEY, UNITED KINGDOM, VENEZUELA, and YEMEN..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0911-2014) 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 February 12, 2014. 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.