Z-0389-2022Class II

Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system

Name: Z-0389-2022 Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Creator: Xstrahl Limited
Published: 2021-08-27
License: https://open.fda.gov/license/

Xstrahl Limited / initiated 2021-08-27 / Terminated / root cause: design

FDA source

Xstrahl Limited began a recall of Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system on 2021-08-27. FDA classified it as Class II and gives the reason as "Base plate may detach from the main body of the treatment applicator". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0389-2022
Classification: Class II
Status: Terminated
Initiated: 2021-08-27
Posted: 2021-12-16
Terminated: 2026-03-04
Recalling firm: Xstrahl Limited
Product: Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Product code: JAD System, Therapeutic, X-Ray
Reason for recall: Base plate may detach from the main body of the treatment applicator.
Root cause tag: design
FDA root cause: Device Design
Action: The firm notified their consignees by email on 08/27/2021. The notice requested the following actions be taken: Xstrahl Limited are issuing the following inspection advice for all X150 specifical system users. 1. Prior to any clinical exposure the operator of the system should inspect the treatment applicator prior to inserting it into the treatment head of the X150. 2. As part of the daily assurance process the treatment applicators should be inspected. 3. If a treatment applicator is dropped it should be inspected by medical physics to ensure it is not damaged. 4. If the base plate is missing the applicators must be withdrawn from clinical use until it is repaired and accepted by medical physics. 5. In the case of an applicator where the base plate has become detached, review the prescription history for the patients for whom that applicator was prescribed. 6. Please advise Xstrahl Limited if you believe patients have been treated with a base plate missing, with detail of the applicator size and clinical filter, kV and HVL, and we will contact you directly.
Quantity in commerce: 120 applicators
Distribution: US and ALGERIA, AUSTRALIA, AUSTRIA, BULGARIA, CANADA, COSTA RICA, CROATIA, CYPRUS, DENMARK, FRANCE, GERMANY, HONG KONG, IRELAND, ITALY, KAZAKHSTAN, LATVIA, MALTA, MEXICO, NEW ZEALAND, NORWAY, PANAMA, ROMANIA, RUSSIA, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, UK, UKRAINE
Product codes and lots: GM0072, GM0077, GM0086, GM0117, GM0131, GM0158, GM0184, GM0189, GM0275, GM0307, GM0338, GM0379, GM0414, GM0469, GM0506

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0389-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0389-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-22	2021-12-16

Product code JAD

K962613Class IIDarpac 2000 Superficial X-Ray Therapy SystemGulmay Medical , Ltd. / cleared 1996-09-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)