Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported August 7, 2019
Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Elekta Inc recalled Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System - a moderate-severity action.
Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System was recalled by Elekta Inc in August 7, 2019. Reason: When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, …. Check the official notice for the remedy. Verify recall #Z-2091-2019 with the FDA Devices before acting.
The recall
Elekta Inc issued this moderate-severity FDA Devices recall-When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, ….
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- August 7, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2091-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2091-2019) was formally reported on August 7, 2019, with the manufacturer initiating the action on July 3, 2019. It is classified under Moderate severity (Class II), with a current status of Ongoing. Elekta Inc is listed as the recalling firm, operating out of Maryland Heights, MO. Federal records list the affected scope as 1396 units.
The documented reason for this recall is: When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly. Distribution data in the federal record shows the product reached: worldwide. 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 - 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 - 40,422 medical devices recalls on record
Where this recall sits in the database
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
1396 units
Related Recalls
6
0 from same agency
Product description
Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
Reason for recall
When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2091-2019 |
| Date reported | August 7, 2019 |
| Date initiated | July 3, 2019 |
| Recalling firm | Elekta Inc |
| Firm location | Maryland Heights, MO |
| Affected scope | 1396 units |
| Distribution | worldwide |
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-2091-2019) 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? ▼
Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System. Recalled by Elekta Inc. Units affected: 1396 units.
Why was this product recalled? ▼
When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 7, 2019. Severity: Moderate. Recall number: Z-2091-2019.
Where was the recalled product distributed? ▼
Distribution: worldwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2091-2019) 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.
CPSC Moderate
Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards
· 2026-07-02
CPSC Moderate
Winco Fireworks International Recalls Roman Candles 8 Shot Fireworks Due to Risk of Serious Injury from Explosion and B…
· 2026-07-02
CPSC Moderate
Winco Fireworks International Recalls Unity 7 Shot 200 Gram Aerial Cake Fireworks Due to Risk of Serious Injury from Ex…
· 2026-07-02
CPSC Moderate
Daikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps Due to Risk of Serious Injury f…
· 2026-06-25
CPSC Moderate
Super Off-Road Solar Power Banks Recalled Due to Overheating; Imported by Spector & Co.
· 2026-06-25
Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →
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 August 7, 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 July 2026.