Every recall we track for Reflexion Medical, Inc. — 4 in all — plus the complaints and injury reports the public filed about them.
Reflexion Medical recalls X1 Radiotherapy System Model RXM1000 with software versions 2.1.29-4 and 2.1.35-1 due to potential dose misdelivery. Affected units may receive 5mm+ displacement or 10-20% underdose.
Reflexion Medical recalls specific models of X1 radiation therapy systems due to software configuration that could allow more than two fractions in 12 hours, potentially causing toxicity. Affected units have unique UDI codes listed.
Reflexion Medical recalls X1 Radiotherapy System software version 2.1.19-3 due to potential dose errors for patients treated with out-of-session SCINTIX partial fractions. Affected units have specific UDI codes.
Reflexion Medical recalls RXM1000 radiotherapy systems due to dose discrepancies when treating patients in Feet First Supine (FFS) positions. Affected units have specific serial numbers and model labels.