| Date Initiated by Firm | April 13, 2015 |
|---|
| Date Posted | May 29, 2015 |
|---|
| Recall Status1 |
Terminated 3 on October 01, 2015 |
| Recall Number | Z-1695-2015 |
|---|
| Recall Event ID |
71231 |
| 510(K)Number | K060937 |
|---|
| Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
| Product | Brilliance iCT Computed Tomography X-ray system |
|---|
| Code Information |
Model# 728306; Serial #'s: 85019 & 85023. |
Recalling Firm/
Manufacturer |
Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
|
| For Additional Information Contact | Mr. Yuchol Kim
440-483-7600 |
|---|
Manufacturer Reason
for Recall | A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mounting fasteners. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Philips sent an Urgent - Field Safety Notice dated April 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Philips Healthcare is recommending to stop the use of your system until the X-ray tube mounting fasteners are replaced.
In addition, a Philips Field Service Engineer (FSE) will service your system via a
Mandatory Field Change Order (FCO 72800638). A Philips FSE will contact you
to schedule this appointment.
If you need any further information or support concerning this issue, please contact your local Philips representative or your local Philips Healthcare office.
This notice has been submitted to the appropriate Regulatory Agency.
Philips apologizes for any inconveniences this problem has caused your organization. For further questions please call (440) 483-7600. |
|---|
| Quantity in Commerce | 2 |
|---|
| Distribution | Internationally to the countries of China and Norway. |
|---|
| 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
|
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