FDA Medical Device Recalls (openFDA)
Xstrahl Limited: Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
- Recall number
- Z-0389-2022
- Recalling firm
- Xstrahl Limited
- Product
- Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
- Status
- Terminated
- Initiated
- 2021-08-27
- Posted
- not on file
- Terminated
- 2026-03-04
- Reason
- Base plate may detach from the main body of the treatment applicator.
- 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 If the base plate is missing the applicators must be withdrawn from clinical use until it is repaired and accepted by medical physics. 5.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
- 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
- Lot, serial or model codes
- GM0072, GM0077, GM0086, GM0117, GM0131, GM0158, GM0184, GM0189, GM0275, GM0307, GM0338, GM0379, GM0414, GM0469, GM0506
- 510(k) numbers
- ["K962613"]
- PMA numbers
- not on file
- Product code
- JAD
- Firm FEI
- 3004561814
- Firm city
- Walsall
- Firm state
- not on file
- Firm country
- United Kingdom
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
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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