Reflexion Medical, Inc. recalls RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00
See all recalls from Reflexion Medical, Inc. →Recalled Product
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Hazard / Issue
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 leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose.
Issued by
FDA
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for RefleXion X1 Radiotherapy System →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
Get the next US recall alert before it hits the news.
Free. Weekly digest or instant alerts. Unsubscribe anytime.
CAN-SPAM compliant · No spam · Unsubscribe anytime