Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 22, 2018
MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.
QFix has advised Mevion Medical Systems that they are identifying unauthorized combinations of QFix Couch Tops with non-QFix devices in clinical use. The kVue Oen Touch latch cons…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Mevion Medical Systems, Inc. recalled MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indica… - a moderate-severity action.
MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indica… was recalled by Mevion Medical Systems, Inc. in August 22, 2018. Reason: QFix has advised Mevion Medical Systems that they are identifying unauthorized combinations of QFix Couch Top…. Check the official notice for the remedy. Verify recall #Z-2746-2018 with the FDA Devices before acting.
The recall
Mevion Medical Systems, Inc. issued this moderate-severity FDA Devices recall-QFix has advised Mevion Medical Systems that they are identifying unauthorized combinations of QFix Couch Top….
- Moderate
- severity level
- 7 units
- affected scope
- Class II
- classification
- August 22, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2746-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2746-2018) was formally reported on August 22, 2018, with the manufacturer initiating the action on June 29, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Mevion Medical Systems, Inc. is listed as the recalling firm, operating out of Littleton, MA. Federal records list the affected scope as 7.
The documented reason for this recall is: QFix has advised Mevion Medical Systems that they are identifying unauthorized combinations of QFix Couch Tops with non-QFix devices in clinical use. The kVue Oen Touch latch consists of a precision latch mechanism that… Distribution data in the federal record shows the product reached: US Nationwide Distribution in the states of DC, FL, MO, NJ, OH, and OK.. 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
7
Related Recalls
6
3 from same agency
Product description
MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.
Reason for recall
QFix has advised Mevion Medical Systems that they are identifying unauthorized combinations of QFix Couch Tops with non-QFix devices in clinical use. The kVue Oen Touch latch consists of a precision latch mechanism that can be damaged when used with incompatible (third-party) accessories. This can create unsafe conditions for use and may compromise the subsequent use of any kVue inserts, whether authorized or not. Use of unauthorized or unvalidated inserts may lead to an incorrect patient treatment or physical injury.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2746-2018 |
| Date reported | August 22, 2018 |
| Date initiated | June 29, 2018 |
| Recalling firm | Mevion Medical Systems, Inc. |
| Firm location | Littleton, MA |
| Affected scope | 7 |
| Distribution | US Nationwide Distribution in the states of DC, FL, MO, NJ, OH, and OK. |
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-2746-2018) 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? ▼
MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.. Recalled by Mevion Medical Systems, Inc.. Units affected: 7.
Why was this product recalled? ▼
QFix has advised Mevion Medical Systems that they are identifying unauthorized combinations of QFix Couch Tops with non-QFix devices in clinical use. The kVue Oen Touch latch consists of a precision latch mechanism that can be damaged when used with incompatible (third-party) accessories. This can create unsafe conditions for use and may compromise the subsequent use of any kVue inserts, whether authorized or not. Use of unauthorized or unvalidated inserts may lead to an incorrect patient treatment or physical injury.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 22, 2018. Severity: Moderate. Recall number: Z-2746-2018.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution in the states of DC, FL, MO, NJ, OH, and OK..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2746-2018) 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 August 22, 2018. 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.