Mevion Medical Systems Recalls MEVION S250 Proton Beam Therapy Systems
Mevion Medical Systems is recalling seven MEVION S250 and S250i proton beam therapy systems due to unauthorized accessory combinations that may cause patient injury.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where the use of unauthorized accessories may lead to incorrect patient treatment or physical injury, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Mevion Medical Systems, Inc. is recalling seven units of the MEVION S250 and MEVION S250i Proton Beam Radiation therapy systems. The recall involves serial numbers S250-0001 through S250-0006 and S250i-0007. These systems were distributed in the United States in the District of Columbia, Florida, Missouri, New Jersey, Ohio, and Oklahoma.
The recall was initiated after QFix advised Mevion Medical Systems that unauthorized combinations of QFix Couch Tops with non-QFix devices were being used in clinical settings. The kVue Oen Touch latch mechanism can be damaged when used with incompatible third-party accessories. This damage can create unsafe conditions and compromise the use of kVue inserts, potentially leading to incorrect patient treatment or physical injury.
The affected systems are indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to radiation treatment. No specific instructions for consumers or patients are provided in the source text.
The recalled product
- Product
- 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.
- Manufacturer
- Mevion Medical Systems, Inc.
- Affected units
- 7
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- S250-0001 through S250-0006 and S250i-0007
Distribution
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