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U.S. Department of Health and Human Services

Class 2 Device Recall AccuSeed DS Digital Stepper

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  Class 2 Device Recall AccuSeed DS Digital Stepper see related information
Date Initiated by Firm November 09, 2006
Date Posted November 29, 2006
Recall Status1 Terminated 3 on November 30, 2007
Recall Number Z-0221-2007
Recall Event ID 36665
510(K)Number K963302  
Product Classification radioactive seed placement system - Product Code ITX
Product AccuSeed DS Digital Stepper, an accessory to a prostate radiation treatment planning system. Model #DS300
Code Information All Model #DS300 steppers
Recalling Firm/
Manufacturer
Computerized Medical Systems Inc
1145 Corporate Lake Dr Ste 100
Saint Louis MO 63132-1716
For Additional Information Contact Michael A. Parsons
314-993-0003
Manufacturer Reason
for Recall
The In/Out adjustment knob can be over-turned, ultimately causing the incorrect placement of radioactive seeds in the patient.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = ITX and Original Applicant = TAYMAN MEDICAL, INC.
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