| Date Initiated by Firm | April 13, 2021 |
|---|
| Create Date | June 02, 2021 |
|---|
| Recall Status1 |
Terminated 3 on September 23, 2022 |
| Recall Number | Z-1774-2021 |
|---|
| Recall Event ID |
87872 |
| 510(K)Number | K060937 |
|---|
| Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
| Product | BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body.
Model Number: 728306 |
|---|
| Code Information |
Serial Numbers: 100100, 100434 |
| FEI Number |
3016618143
|
Recalling Firm/
Manufacturer |
Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
|
Manufacturer Reason
for Recall | Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | Philips Regional Service Manager spoke to Customer on 13 April 2021, and advised them to stop use of the product until repair could be completed and followed communication by email. On 14-Apr-2021 component was replaced and system returned to service. |
|---|
| Quantity in Commerce | 2 units (1 US and 1 OUS) |
|---|
| Distribution | Worldwide distribution - US Nationwide distribution in the state of NV and the country of Japan. |
|---|
| 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
|
|---|
