Z-0221-2007

AccuSeed DS Digital Stepper, an accessory to a prostate radiation treatment planning system. Model #DS300

Name: Z-0221-2007 AccuSeed DS Digital Stepper, an accessory to a prostate radiation treatment planning system. Model #DS300
Creator: Computerized Medical Systems Inc
Published: 2006-11-09
License: https://open.fda.gov/license/

Elekta Limited / initiated 2006-11-09 / Terminated

FDA source

Computerized Medical Systems Inc began a recall of AccuSeed DS Digital Stepper, an accessory to a prostate radiation treatment planning system. Model #DS300 on 2006-11-09. The reason FDA records is "The In/Out adjustment knob can be over-turned, ultimately causing the incorrect placement of radioactive seeds in the patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0221-2007
Status: Terminated
Initiated: 2006-11-09
Posted: 2006-11-29
Terminated: 2007-11-30
Recalling firm: Elekta Limited
Product: AccuSeed DS Digital Stepper, an accessory to a prostate radiation treatment planning system. Model #DS300
Product code: ITX Transducer, Ultrasonic, Diagnostic
Reason for recall: The In/Out adjustment knob can be over-turned, ultimately causing the incorrect placement of radioactive seeds in the patient.
FDA root cause: Other
Action: The recalling firm issued letters dated 11/9/06 via regular mail. The letter informs the customer of the problem and includes an advisory notice instructing them to perform a test prior to each use. If the system does not function correctly, it can still be used safely in a manual mode until it can be returned for repair. A questionnaire was enclosed that will facilitate the firm in prioritizing repairs and retrofits. After the questionnaire is reviewed, the firm will contact the customer for further information regarding their facilities use of the device. This letter was also issued to the CMS customer support departments in Japan, China, and Europe, who will notify the foreign customers and prioritize their returns for repair.
Quantity in commerce: 62 steppers
Distribution: Worldwide, including USA, Australia, Japan, China, France, Germany and Brazil.
Product codes and lots: All Model #DS300 steppers

Product code ITX

K963302Class IITayman Medical, Inc. Stepping & Stabilizing SystemTayman Medical, Inc. / cleared 1997-02-06

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)