RefleXion X1 may deliver radiotherapy dose to the incorrect location

Plain-English summary

RefleXion Medical, Inc. is recalling the RefleXion X1 Radiotherapy System, model RXM1000, part 800-00006-00, running software versions 2.1.29-4 and 2.1.35-1. About 12 units were distributed across eight US states. The FDA has classified this recall as Class II.

Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery. This leads to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5 mm or higher, with a 10% to 20% underdose.

Affected systems carry UDI 00860003983812 across twelve listed serial numbers beginning X11001.

Facilities can identify affected systems by the model, software version and serial number, and may contact RefleXion Medical, Inc. for further information.

The recalled product

Product

RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00

Manufacturer

Reflexion Medical, Inc.

Category

Medical Device — Radiotherapy

Hazard

• software-defect
• dose-misplacement
• underdose
• treatment-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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