| Class 2 Device Recall MOSAIQ versions 1.3 and 1.4 SEQUENCER |  |
Date Initiated by Firm | February 14, 2008 |
Date Posted | August 16, 2008 |
Recall Status1 |
Terminated 3 on June 24, 2009 |
Recall Number | Z-1515-2008 |
Recall Event ID |
46941 |
510(K)Number | K981313 |
Product Classification |
Radiation Therapy Treatment - Product Code IYE
|
Product | SEQUENCER, MOSAIQ versions 1.3 and 1.4 with Elekta and Siemens Machines, Model number 40003-001000-RO, Manufactured by IMPAC Medical Systems, Sunnyvale, CA.
Used to facilitate the delivery of defined radiotherapy treatment plans. |
Code Information |
MOSAIQ versions 1.30 and 1.40 with Elekta iCom or Siemens DMIP |
Recalling Firm/ Manufacturer |
Impac Medical Systems Inc 100 Mathilda Pl Fl 5th Sunnyvale CA 94086-6076
|
For Additional Information Contact | 408-830-8007 |
Manufacturer Reason for Recall | Software issue may result in change to intended treatment field, potentially resulting in mistreatment. |
FDA Determined Cause 2 | Software design |
Action | Firm issued field advisory to its consignees on 02/14/2008. Phone calls will also be made to affected customers to ensure reception and understanding of the field notification. Firm advises users with affected product to review the jaw positions of IMRT fields to ensure that they match the RT Plan after an Apply Limits or Machine Change occurs, until software at their site can be updated to the corrected version. A software patch is under construction. |
Quantity in Commerce | 36 units |
Distribution | Worldwide Distribution --- USA including states of OH, OK, NJ, MN, OR, TN, NY, CA, AZ, NV, IA, GA, AL, MD, MI, PA, IN, WA, FL, TX, CO, and countries to Canada, Australia, Germany, Greece and Sweden. |
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 = IYE
|
|
|
|