Date Initiated by Firm | April 25, 2023 |
Date Posted | July 28, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2261-2023 |
Recall Event ID |
92202 |
510(K)Number | K180015 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
Product | Incisive CT Plus-Computed Tomography X-Ray System
Model: 728149 |
Code Information |
UDI-DI: (01)00884838103474(21)
Serial Numbers:
530408
530437
530474
530320
530332
530430
|
Recalling Firm/ Manufacturer |
Philips North America 222 Jacobs St Cambridge MA 02141-2296
|
For Additional Information Contact | Philips Customer Care Solutions Center 800-722-9377 |
Manufacturer Reason for Recall | Metal mounting box on the rotating scanner on rotor
(heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Phiips issued Urgent Medical Device Correction Letters mailed to US consignees via Certified United States Postal Service (USPS) with delivery confirmation on 4/25/23
International global markets were notified of the issue and instructed to distribute the
FSN to affected consignees in accordance with local requirements.
Letter states reason for recall, health risk and action to take:
Please continue to use your system in accordance with its intended use. If you need to
remain in the room for the duration of a scan, Philips recommends using protective
eyewear.
" Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. Please retain this letter with your system(s) until a solution is installed on your system; ensure the letter is in a place likely to be seen/viewed.
" Place this URGENT Medical Device Correction Letter with your system documentation.
" Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction Letter, understanding of the issue, and required actions to be taken.
Philips will contact you to schedule a time for a Field Service Engineer (FSE) to visit your site and install a solution to address the issue (reference FCO72800798).
If you need additional information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377). |
Quantity in Commerce | 6 units OUS |
Distribution | Nationwide
Foreign:
China
Algeria
Argentina
Australia
Austria
Azerbaijan
Bahrain
Bangladesh
Belarus
Belgium
Bolivia
Brazil
Bulgaria
Canada
Chile
China
Colombia
Czech Republic
Ecuador
Egypt
France
Germany
Greece
India
Indonesia
Iran
Iraq
Israel
Italy
Japan
Jordan
Korea, Republic of
Kosovo
Latvia
Macedonia
Mexico
Moldova
Netherlands
Nigeria
Pakistan
Panama
Philippines
Poland
Romania
Russian Federation
Saint Lucia
Saint Pierre and Miquelon
Saudi Arabia
Serbia
Slovakia
Spain
Sweden
Taiwan
Thailand
Tunisia
Turkey
Turkmenistan
United Kingdom
Uzbekistan
Viet Nam
|
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = JAK
|