Date Initiated by Firm | November 08, 2017 |
Create Date | January 11, 2018 |
Recall Status1 |
Terminated 3 on April 17, 2020 |
Recall Number | Z-0332-2018 |
Recall Event ID |
78879 |
510(K)Number | K060937 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product | Philips Healthcare Brilliance iCT SP computed tomography x-ray system |
Code Information |
Brilliance iCT SP - 728311 Devices manufactured 03/05/2009 to present. |
Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Rd Cleveland OH 44143-2131
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For Additional Information Contact | Holly Wright Lee 440-483-7600 |
Manufacturer Reason for Recall | There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs,
the part(s) will not be expelled, however, a noise may be heard coming from the gantry.
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FDA Determined Cause 2 | Device Design |
Action | Philips Healthcare is informing consignees of this issue through a Customer Information Letter (CIL_FCO72800690). Philips Key Market representatives will distribute the letter internationally, based on local regulations. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. Customers are notified that if they hear an unusual noise coming from the gantry, or scan halts, the Philips representative should be contacted as soon as possible. Philips will be inspecting the affected systems, tightening and replacing the reaction ring screws as needed at no additional cost. |
Quantity in Commerce | 134 |
Distribution | 107 domestic accounts
15 US Govt accounts
682 Foreign Accounts
3 Mexico accounts
12 Canada accounts |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JAK
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