Recall Z-0221-2007 ยท ITX Transducer, Ultrasonic, Diagnostic
Computerized Medical Systems Inc
AccuSeed DS Digital Stepper, an accessory to a prostate radiation treatment planning system. Model #DS300
| Date | Nov 29, 2006 (initiated Nov 9, 2006) |
| Status | Terminated |
| 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 |
| Quantity | 62 steppers |
| Distribution | Worldwide, including USA, Australia, Japan, China, France, Germany and Brazil. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963302 | TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM Tayman Medical, Inc., Feb 6, 1997 |