Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall uCT 550

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall uCT 550see related information
Date Initiated by FirmMay 23, 2020
Date PostedJuly 20, 2020
Recall Status1 Open3, Classified
Recall NumberZ-2641-2020
Recall Event ID 85771
510(K)NumberK181414 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductComputed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck and vascular).
Code Information Serial Numbers: 353020, 353021, and 353023 with software version R001.11.0.729741-Re-1100
FEI Number 3011015597
Recalling Firm/
Manufacturer		 Shanghai United Imaging Healthcare Co., Ltd.
No. 2258 Chengbei Rd, Jiading Ind.
Shanghai China
Manufacturer Reason
for Recall		Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium.
FDA Determined
Cause 2		Software design
ActionOn 05/23/2020, Customer Notification Letters dated 5/22/2020 were emailed to customers. Customers were asked to do the following: For safety issue 1: If you observe image artifacts, please reboot the system and continue the reconstruction. If the image artifacts persist, please contact the recalling firm's service support team or call the Customer Contact Center at (855) 221-1552 (toll free) or (832) 699-2799 (direct). For safety issue 2: If the scout scanning is interrupted, try repeating the scout scanning. If problem persists, please contact the recalling firm's service support team or call the Customer Contact Center at (855) 221-1552 (toll free) or (832) 699-2799 (direct). Customers were asked to notify all users of the affected products via Customer Notification Letter. On 8/30/2024, a correction notice was sent identifying an additional serial number.
Quantity in Commerce3
DistributionUS Distribution to state of: TX
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = JAK
-
-