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U.S. Department of Health and Human Services

Class 2 Device Recall IntelliC

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 Class 2 Device Recall IntelliCsee related information
Date Initiated by FirmApril 27, 2023
Date PostedMay 31, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1668-2023
Recall Event ID 92230
510(K)NumberK173631 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductIntelli-C, Right side suspended Tabletop, REF: 03400000
Code Information UDI-DI: 05713464000527/Serial Numbers: 627004, 627007, 639001, 639002,639003, 639004, 639007, 639010, 647001, 647004, 647005, 648001, 651007, 658002, 658003, 658006, 658010, 666008, 675001, 675004, 682006, 682010
FEI Number 1000188474
Recalling Firm/
Manufacturer		 NRT X-RAY A/S
Birkegardsvej 16
Hasselager Denmark
For Additional Information ContactJan Malling
86 28 35 00
Manufacturer Reason
for Recall		There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which causes the detector to move until it is stopped by the movement end-stop.
FDA Determined
Cause 2		Device Design
ActionBetween the dates of April 27, 2023 - May 1, 2023, NRT X-Ray A/S issued a "urgent: Medical Device Correction" via E-Mail to affected consignees. Per the customer communication, NRT ask consignees to take the following actions: Step 1 Short term action The first step of the recall is a corrective action which requires the existing fixation bracket components to be removed. Service Providers of the Intelli-C systems should follow the instructions in page 4 through 7 of the communication and report back to NRT using the Customer Response Card on page 8. The process is coordinated through US dealer Alpha Imaging in Willoughby, Ohio. Step 2 Long term action The second step is a preventive action to replace the IDE drive shaft and relating components. A separate set of instructions for this action will be provided in May together with the required parts for the replacement. These instructions will include a separate acknowledgement form for this action. If you have questions regarding the contents of this letter, please contact your local Service provider or contact NRT X-RAY A/S directly using the following contact information: Email: aqr@nrtxray.com Phone: +45 2055 3309 Monday through Friday, (03:00)-11:00 Eastern Standard Time (9:00 AM to 5:00 PM, Central European Time)
Quantity in Commerce32 units
DistributionUS Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, LA, NV, NY.
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 = OWB
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