The Recall Desk

Manufacturer

Xstrahl Limited

3 recalls in our database name Xstrahl Limited as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2022-07-27

Of the 3 recalls from Xstrahl Limited we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–3 of 3

  • ModerateFDA (Devices)·Z-1404-2022·2022-07-27

    X80 RADiant Photoelectric Therapy System Compatibility Issue

    Xstrahl Limited is recalling specific lot codes of the X80 RADiant Photoelectric Therapy System due to a potential compatibility issue with replacement treatment applicators. Devices were distributed in Florida, California, and Kentucky.

    Product
    X80 RADiant Photoelectric Therapy System
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0389-2022·2021-12-22

    X-ray therapy applicator base plates may detach from device body

    Xstrahl Limited is recalling treatment applicators for Gulmay Medical 150 and Xstrahl 150 X-ray therapy systems. The base plate may detach from the applicator body, potentially affecting treatment positioning and delivery.

    Product
    Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0174-2022·2021-11-03

    Xstrahl Concerto Software Fails to Update Opposing Beam Treatment Parameters

    Xstrahl's Concerto software used in X-ray therapy systems may fail to update treatment parameters for a second beam when a treatment plan is edited. This could result in error messages and incorrect treatment delivery.

    Product
    Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray Therapy System; (2) Xstrahl 150 Electronic Brachytherapy - 150kV Superficial X-Ray Therapy System; (3) Xstrahl 200 - 225kV Superficial / O
    Category
    Medical Device
    Distribution
    Distributed nationwide