FDA Medical Device Recalls (openFDA)
Reflexion Medical, Inc.: RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
- Recall number
- Z-1656-2026
- Recalling firm
- Reflexion Medical, Inc.
- Product
- RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
- Status
- Open, Classified
- Initiated
- 2026-02-09
- Posted
- 2026-03-27
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Software change control
- Action
- On 2/9/2026, recall notices were emailed to customers who were informed of the following: How to recognize that the device may fail: Any patient treatment with a roll offset applied in a localization followed by a subsequent repeat localization within the same treatment session will be affected. For patient treatments that have already occurred, measuring the approximate distance off-axis (R) and the maximum roll offset value (., in radians) can provide an approximate displacement value (S) through a simple mathematical formula, which may be helpful in estimating the severity of the dose impact for the patient. Customers were asked to do the following: 1) Notify your clinical staff of the recall, including posting this notification on or near the system until this issue can be resolved. 2) Halt utilization of the Repeat Localization feature for all treatment and imaging sessions. a. Note: Standard Roll corrections may still be used on the system if they are only applied in the localization immediately prior to the treatment delivery or imaging session commencing, as those are unaffected by this issue. 3) If a Roll correction is applied in an initial Localization and a Repeat Localization is initiated, the user should end the treatment session without continuing to treatment delivery or PET imaging. The user should restart the treatment session as a new treatment session to properly apply the Roll correction in the initial Localization without performing a Repeat Localization afterwards. 4) Complete and return the acknowledgement form. Questions or additional assistance can be sent to the firm at support@reflexion.com
- Quantity
- 12
- Distribution
- US: CA, TX, PA, CT, NJ, OR, LA, OH
- Lot, serial or model codes
- Software Version: 2.1.29-4 and Software Version: 2.1.35-1. UDI: (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, (01)00860003983812(11)240528(21)X11009, (01)00860003983812(11)240820(21)X11010, (01)00860003983812(11)241107(21)X11011, (01)00860003983812(11)241206(21)X11012, (01)00860003983812(11)250731(21)X11013.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QVA
- Firm FEI
- 3011716550
- Firm city
- Hayward
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28