FDA Medical Device Recalls (openFDA)
NRT X-RAY A/S: Intelli-C, Right side suspended Tabletop, REF: 03400000
- Recall number
- Z-1668-2023
- Recalling firm
- NRT X-RAY A/S
- Product
- Intelli-C, Right side suspended Tabletop, REF: 03400000
- Status
- Open, Classified
- Initiated
- 2023-04-27
- Posted
- 2023-05-31
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Device Design
- Action
- Between 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
- 32 units
- Distribution
- US Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, LA, NV, NY.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K173631"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 1000188474
- Firm city
- Hasselager
- Firm state
- not on file
- Firm country
- Denmark
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28