Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
Reported: April 6, 2022 Initiated: February 1, 2022 #Z-0827-2022
Product Description
Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
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.
Details
- Recalling Firm
- Mevion Medical Systems, Inc.
- Units Affected
- 39 (36 US, 3 OUS)
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, MO, NJ, OH, OK, UT, DC and the country of Netherlands.
- Location
- Littleton, MA
Frequently Asked Questions
What product was recalled? ▼
Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808). Recalled by Mevion Medical Systems, Inc.. Units affected: 39 (36 US, 3 OUS).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 6, 2022. Severity: Moderate. Recall number: Z-0827-2022.
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