|
Class 2 Device Recall IntelliC |
|
Date Initiated by Firm |
April 17, 2024 |
Date Posted |
May 07, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1784-2024 |
Recall Event ID |
94363 |
510(K)Number |
K173631
|
Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
Product |
Intelli-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 |
Recalling Firm/ Manufacturer |
NRT X-RAY A/S Birkegardsvej 16 Hasselager Denmark
|
For Additional Information Contact |
Jan 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 |
Action |
On 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 Commerce |
35 |
Distribution |
US 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 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.
|
510(K) Database |
510(K)s with Product Code = OWB and Original Applicant = NRT X-ray A/S
|
|
|
|