Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 22, 2015
Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.
GE Healthcare has recently become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical lamp. The pendent system was not i…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ge Healthcare recalled Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray… - a moderate-severity action.
Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray… was recalled by Ge Healthcare in April 22, 2015. Reason: GE Healthcare has recently become aware of an improper installation of a ceiling suspended pendent supporting…. Check the official notice for the remedy. Verify recall #Z-1441-2015 with the FDA Devices before acting.
The recall
Ge Healthcare issued this moderate-severity FDA Devices recall-GE Healthcare has recently become aware of an improper installation of a ceiling suspended pendent supporting….
- Moderate
- severity level
- Class II
- classification
- April 22, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1441-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1441-2015) was formally reported on April 22, 2015, with the manufacturer initiating the action on March 9, 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 797 (3 US, 794 OUS)..
The documented reason for this recall is: GE Healthcare has recently become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical lamp. The pendent system was not installed per specified installation requ… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Distribution to the states of : CA and MA., and to the countries of : SPAIN, INDIA, JAPAN, AZERBAIJAN, BULGARIA, BELARUS, SWITZERLAND, CZECH REPUBLIC, GERMANY, EGYPT, FINLAND, FRANCE, UNITED …. 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
797 (3 US, 794 OUS).
Related Recalls
6
3 from same agency
Product description
Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.
Reason for recall
GE Healthcare has recently become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical lamp. The pendent system was not installed per specified installation requirements. There has been a reported incident of a radiation shield falling from the ceiling causing a minor injury.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1441-2015 |
| Date reported | April 22, 2015 |
| Date initiated | March 9, 2015 |
| Recalling firm | Ge Healthcare |
| Firm location | Waukesha, WI |
| Affected scope | 797 (3 US, 794 OUS). |
| Distribution | Worldwide Distribution - US Distribution to the states of : CA and MA., and to the countries of : SPAIN, INDIA, JAPAN, AZERBAIJAN, BULGARIA, BELARUS, SWITZERLAND, CZECH REPUBLIC, GERMANY, EGYPT, FINLAND, FRANCE, UNITED KINGDOM, GUYANA, IRE… |
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-1441-2015) 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? ▼
Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.. Recalled by Ge Healthcare. Units affected: 797 (3 US, 794 OUS)..
Why was this product recalled? ▼
GE Healthcare has recently become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical lamp. The pendent system was not installed per specified installation requirements. There has been a reported incident of a radiation shield falling from the ceiling causing a minor injury.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 22, 2015. Severity: Moderate. Recall number: Z-1441-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Distribution to the states of : CA and MA., and to the countries of : SPAIN, INDIA, JAPAN, AZERBAIJAN, BULGARIA, BELARUS, SWITZERLAND, CZECH REPUBLIC, GERMANY, EGYPT, FINLAND, FRANCE, UNITED KINGDOM, GUYANA, IRELAND, ISRAEL, ITALY, NIGERIA and NORWAY..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1441-2015) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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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 April 22, 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.