AccuSeed DS Digital Stepper, an accessory to a prostate radiation treatment planning system. Model #DS300
FDA device recall Z-0221-2007 · posted 2006-11-29 · Terminated
Recall details
- Recalling firm
- Computerized Medical Systems Inc
- Reason for recall
- The In/Out adjustment knob can be over-turned, ultimately causing the incorrect placement of radioactive seeds in the patient.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- ITX
- Quantity affected
- 62 steppers
- Distribution
- Worldwide, including USA, Australia, Japan, China, France, Germany and Brazil.
- Date initiated
- 2006-11-09
- Date posted
- 2006-11-29
- Date terminated
- 2007-11-30
- Location
- Saint Louis, MO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM (K963302) | Tayman Medical, Inc. | 1997-02-06 |