Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
Summary
The FDA issued a Class II for Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 3780 by Mevion Medical Systems, Inc.. Reason: Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if.
Details
Source
Device Recall
External ID
Z-0827-2022
Action Date
2022-04-06
Status
Ongoing
Category
device
Product Description
Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
Lot/Code Info: All theryapy systems, all hand pendant serial numbers. Therapy system UDI 00864366000100 and UDI 00864366000124.
Quantity Affected: 39 (36 US, 3 OUS)
Reason for Recall
Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other objects in the treatment room.
Distribution
Worldwide distribution - US Nationwide distribution in the states of FL, MO, NJ, OH, OK, UT, DC and the country of Netherlands.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-01
Company
Littleton, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 123 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Mevion Medical Systems, Inc. has 3 FDA actions in our database, including 1 recall and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mevion Medical Systems, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mevion Medical Systems, Inc. have FDA actions?
Mevion Medical Systems, Inc. has 3 FDA actions in our database, including 1 recall and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0827-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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