| | Class 3 Device Recall MX8000 Computed Tomography Xray System |  |
| Date Initiated by Firm | April 02, 2003 |
|---|
| Date Posted | May 15, 2003 |
|---|
| Recall Status1 |
Terminated 3 on December 01, 2003 |
| Recall Number | Z-0835-03 |
|---|
| Recall Event ID |
26080 |
| 510(K)Number | K012009 |
|---|
| Product Classification |
System, X-Ray, Tomography, Computed - Product Code JAK
|
| Product | Philips MX8000 IDT CT Scanner, utilizing V2.1 software. |
|---|
| Code Information |
Serial Numbers: 3094 through 3196. |
Recalling Firm/
Manufacturer |
Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Highland Heights OH 44143
|
Manufacturer Reason
for Recall | Patient images may be incorrectly stored in the archive directory of a different patient. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | The firm mailed a ''Product Safety Notification'', dated 4/2/2003, to all affected user sites. |
|---|
| Quantity in Commerce | 137 installed units (59 domestic) |
|---|
| Distribution | The units were installed in medical facilities located nationwide, and in the following foreign countries: China, Belgium, France, Austria, Germany, Italy, Netherlands, Australia, Israel, Spain, Denmark, Singapore, Switzerland, Russia, South Korea, Canada, United Kingdom, South Africa, Sweden, Japan, 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 = JAK
|
|---|
|
|
|
