Siemens Medical Recalls 35 MEVATRON M 6700 Linear Accelerators
Siemens Medical Solutions USA is recalling 35 MEVATRON M 6700 linear accelerators due to a defective weld seam that could cause the overhead suspension to fall and injure a patient or other person.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a medical device that could cause a component to fall and result in severe injury to a patient or other person, meeting the criteria for a Severe (4) rating.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 35 units of the MEVATRON M 6700 (MX) Accelerator, Linear, Medical. The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. The affected devices are distributed nationwide.
The recall is due to a defective weld seam at the overhead suspensions. This defect makes it possible for the weld seam to break, which could cause the overhead suspension to fall down. If this occurs, it can lead to a severe injury to a patient or any other person.
The source text does not specify a date for the recall, the number of reported injuries, or specific instructions for consumers beyond the identification of the hazard. Affected serial numbers are listed in the structured product information.
The recalled product
- Product
- MEVATRON M 6700 (MX) Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 35
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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