Severity
Moderate
ModerateClass IICompleted
FDA Devices recall · Reported January 16, 2019
Elekta Unity
In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and weakening of speaker fixings during the lifetime of the system, the spea…
Elekta Limited recalled Elekta Unity - a moderate-severity action.
Elekta Unity was recalled by Elekta Limited in January 16, 2019. Reason: In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and we…. Check the official notice for the remedy. Verify recall #Z-0706-2019 with the FDA Devices before acting.
The recall
Elekta Limited issued this moderate-severity FDA Devices recall-In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and we….
- Moderate
- severity level
- 2 units
- affected scope
- Class II
- classification
- January 16, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0706-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0706-2019) was formally reported on January 16, 2019, with the manufacturer initiating the action on January 4, 2019. It is classified under Moderate severity (Class II), with a current status of Completed. Elekta Limited is listed as the recalling firm, operating out of Crawley. Federal records list the affected scope as 2 units.
The documented reason for this recall is: In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and weakening of speaker fixings during the lifetime of the system, the speakers can become dislodged and be pulled … Distribution data in the federal record shows the product reached: TX and WI, Germany, Denmark, Netherlands, United Kingdom. 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, 6 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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
2 units
Related Recalls
6
6 from same agency
Product description
Elekta Unity
Reason for recall
In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and weakening of speaker fixings during the lifetime of the system, the speakers can become dislodged and be pulled into the bore.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Completed |
| Recall number | Z-0706-2019 |
| Date reported | January 16, 2019 |
| Date initiated | January 4, 2019 |
| Recalling firm | Elekta Limited |
| Firm location | Crawley |
| Affected scope | 2 units |
| Distribution | TX and WI, Germany, Denmark, Netherlands, United Kingdom |
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-0706-2019) 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? ▼
Elekta Unity. Recalled by Elekta Limited. Units affected: 2 units.
Why was this product recalled? ▼
In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and weakening of speaker fixings during the lifetime of the system, the speakers can become dislodged and be pulled into the bore.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 16, 2019. Severity: Moderate. Recall number: Z-0706-2019.
Where was the recalled product distributed? ▼
Distribution: TX and WI, Germany, Denmark, Netherlands, United Kingdom.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0706-2019) 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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Compare this recall with FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access… →
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 January 16, 2019. 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 August 2026.