CLASS II Device recall · Reported 19 Jan 2022 · FDA Enforcement Report
Radiotherapy System - System Label: "*** refleXion recalled
Reflexion Medical is recalling RefleXion Medical Radiotherapy System - System Label: "*** refleXion, distributed nationwide in the US. The recall was initiated on 24 Nov 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0470-2022
- FDA event ID
- 89212
- Recalling firm
- Reflexion Medical, Hayward, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Nov 2021
- FDA classified
- 10 Jan 2022
- Reported
- 19 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 24 Nov 2021 | Recall initiated by company | |
| 10 Jan 2022 | Classified by FDA | +47 days |
| 19 Jan 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orientation specifically in Feet First Supine (FFS).
Product as listed by the FDA
RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"
Where it was distributed
U.S. Nationwide distribution in the states of CA and TX
Questions about this recall
Is Radiotherapy System - System Label: "*** refleXion recalled?
Yes. Reflexion Medical recalled Radiotherapy System - System Label: "*** refleXion on 24 Nov 2021. The recall is Class II and its status is Terminated. Recall number Z-0470-2022.
Why was it recalled?
Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orientation specifically in Feet First Supine (FFS).
Which lots are affected?
Model: RXM1000 Serial Numbers/UDI Codes: X11001 / (01)00860003983805(11)210125(21)X11001 X11002 / (01)00860003983805(11)210324(21)X11002 X11003 / (01)00860003983805(11)210524(21)X11003
Where was it sold?
U.S. Nationwide distribution in the states of CA and TX
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Reflexion Medical
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | RefleXion X1 Radiotherapy System recalled by Reflexion Medical | Reflexion Medical | Device Malfunction | 8 states |
| Device | CLASS II | RefleXion X1 recalled by Reflexion Medical | Reflexion Medical | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | RefleXion X1 Radiotherapy System recalled by Reflexion Medical | Reflexion Medical | Device Malfunction | 6 states |
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