RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that comb
Summary
The FDA issued a Class II for RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiat by Reflexion Medical, Inc.. Reason: A potential dose error exists for patients treated with an out of session SCINTIX partial fraction..
Details
Source
Device Recall
External ID
Z-1933-2024
Action Date
2024-06-05
Status
Ongoing
Category
device
Product Description
RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a linear accelerator.
Lot/Code Info: Model Number: RXM1000 UDI Codes that includes system serial numbers: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)230505(21)X11003 (01)00860003983812(11)230530(21)X11004 (01)00860003983812(11)230811(21)X11006 (01)00860003983812(11)230410(21)X11007 (01)00860003983812(11)230803(21)X11008
Quantity Affected: 7 systems
Reason for Recall
A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
Distribution
U.S.: CA, CT, NJ, OR, PA and TX No O.U.S.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-16
Company
Hayward, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 258 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Reflexion Medical, Inc. has 6 FDA actions in our database, including 4 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Reflexion Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Reflexion Medical, Inc. have FDA actions?
Reflexion Medical, Inc. has 6 FDA actions in our database, including 4 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1933-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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