Computerized Medical Systems Inc AccuSeed DS Digital Stepper, an accessory to a prostate radiation treatment planning system. Model #DS300 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AccuSeed DS Digital Stepper, an accessory to a prostate radiation treatment planning system. Model #DS300
Brand
Computerized Medical Systems Inc
Lot Codes / Batch Numbers
All Model #DS300 steppers
Products Sold
All Model #DS300 steppers
Computerized Medical Systems Inc is recalling AccuSeed DS Digital Stepper, an accessory to a prostate radiation treatment planning system. Model due to The In/Out adjustment knob can be over-turned, ultimately causing the incorrect placement of radioactive seeds in the patient.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The In/Out adjustment knob can be over-turned, ultimately causing the incorrect placement of radioactive seeds in the patient.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026