Summary
The FDA issued a Class II for Intelli-C, Right side suspended Tabletop, REF: 03400000 by NRT X-RAY A/S. 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 un.
Details
Source
Device Recall
External ID
Z-1668-2023
Action Date
2023-06-07
Status
Ongoing
Category
device
Product Description
Intelli-C, Right side suspended Tabletop, REF: 03400000
Lot/Code Info: 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
Quantity Affected: 32 units
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.
Distribution
US Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, LA, NV, NY.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-27
Company
Hasselager, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
NRT X-RAY A/S has 5 FDA actions in our database, including 4 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (NRT X-RAY A/S) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does NRT X-RAY A/S have FDA actions?
NRT X-RAY A/S has 5 FDA actions in our database, including 4 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1668-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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