| Date Initiated by Firm | May 25, 2004 |
|---|
| Date Posted | July 20, 2004 |
|---|
| Recall Status1 |
Terminated 3 on February 28, 2005 |
| Recall Number | Z-1020-04 |
|---|
| Recall Event ID |
29219 |
| 510(K)Number | K991237 |
|---|
| Product Classification |
System, Planning, Radiation Therapy Treatment - Product Code MUJ
|
| Product | Radionics Head and Neck Localilizer (HNL), Version B |
|---|
| Code Information |
Serial Numbers: 032610023, 0326100023, 32690010, 041200023 |
| FEI Number |
1000120652
|
Recalling Firm/
Manufacturer |
Radionics, Inc.
22 Terry Ave
Burlington MA 01803-2516
|
| For Additional Information Contact | Kevin J. O'Connell
781-565-1227 |
|---|
Manufacturer Reason
for Recall | Software may provide inaccurate coordinates and cause mistreatment |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Radionics notified users by telephone and follow-up letters dated 5/25/04 via facsmile. Users are requested not to use the system. A corrected software will be issued. |
|---|
| Quantity in Commerce | 4 |
|---|
| Distribution | Canada, Germany, Greece |
|---|
| 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 = MUJ
|
|---|
