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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 17, 2024
Date PostedMay 07, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1784-2024
Recall Event ID 94363
510(K)NumberK173631 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductIntelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system
Code Information REF/UDI-DI/Serial Numbers: 03400000/05713464000527/627002, 627004, 627007, 639001, 639002, 639003, 639004, 639007, 639010, 647001, 647004, 647005, 648001, 651007, 658002, 658003, 658006, 658010, 666008, 675001, 675004, 682006, 682010, 682011, 696003, 696004, 696006, 696007, 696012. 03400010/05713464000121/647009, 651002, 651006, 666009, 682003, 682023
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		X-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a faulty setting, 2) the Motor/gear assembly is worn, 3) CAT movement is driven at maximum speed and angulated more than 75 deg. from vertical, and 4) the emergency stop or touch guard is activated during the breaking sequence, which could lead to the C-arm hitting the patient or operator.
FDA Determined
Cause 2		Device Design
ActionOn 04/17/24, correction notices were emailed to consignees who were asked to do the following: 1) If you experience the described uncontrolled motion, stop using the device and contact your service provider to have your device repaired. 2) The correction notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred. 3) Complete and return the response form to either support@nrtxray.com or servicesupport@alpha-imaging.com A firmware update will be made to all motor controllers in the system. The update will be performed by the Service Provider. Customers with recall-related questions can call 1-800-331-7327.
Quantity in Commerce35
DistributionUS Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, WV, LA, NY, PA, HI, NV, WI, MN, MI.
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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