FDA Medical Device Recalls (openFDA)
Computerized Medical Systems Inc: AccuSeed DS Digital Stepper, an accessory to a prostate radiation treatment planning system. Model #DS300
- Recall number
- Z-0221-2007
- Recalling firm
- Computerized Medical Systems Inc
- Product
- AccuSeed DS Digital Stepper, an accessory to a prostate radiation treatment planning system. Model #DS300
- Status
- Terminated
- Initiated
- 2006-11-09
- Posted
- 2006-11-29
- Terminated
- 2007-11-30
- Reason
- The In/Out adjustment knob can be over-turned, ultimately causing the incorrect placement of radioactive seeds in the patient.
- 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
- 62 steppers
- Distribution
- Worldwide, including USA, Australia, Japan, China, France, Germany and Brazil.
- Lot, serial or model codes
- All Model #DS300 steppers
- 510(k) numbers
- ["K963302"]
- PMA numbers
- not on file
- Product code
- ITX
- Firm FEI
- 1937649
- Firm city
- Saint Louis
- Firm state
- MO
- 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