1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combinati
Summary
The FDA issued a Class II for 1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulde by NRT X-RAY A/S. Reason: Friction rubber block in the clamping mechanism was missing in the Footrest. It may slip down along the patient table while in use with a patient. Thi.
Details
Source
Device Recall
External ID
Z-0526-2022
Action Date
2022-02-02
Status
Ongoing
Category
device
Product Description
1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)
Lot/Code Info: 1. Footrest, REF: 03282000, UDI: 05713464000336; Serial Numbers: 903282000046, 903282000057, 903282000075 ,9032820000070, 903282000001, 903282000002, 903282000004 thru 903282000006, 903282000009, 903282000011, 903282000012 903282000015, 903282000016, 903282000018 thru 903282000020, 903282000023, 903282000024, 903282000025, 903282000026, 903282000028, 903282000032 thru 903282000034, 903282000036, 903282000038 thru 903282000042, 903282000044, 903282000045, 903282000047 thru 903282000051, 903282000053, 903282000055, 903282000056, 903282000058 thru 903282000061, 903282000063, 903282000064, 903282000067, 903282000068 2. Shoulder Support, REF: 03283000, UDI: 05713464000381 Serial Numbers: 903283000012, 903283000028, 903283000001 thru 903283000003, 903283000005, 903283000010, 903283000011, 903283000013 thru 903283000022, 903283000023, 903283000024, 903283000026
Quantity Affected: 72 units
Reason for Recall
Friction rubber block in the clamping mechanism was missing in the Footrest. It may slip down along the patient table while in use with a patient. This accessory is designed to use with Intelli-C, Right and Intelli-C, Left.
Distribution
USA: IA, KY,LA, MA, NC,NY, OH, SC, WA, WV OUS: Switzerland, Czech Republic, Germany, Denmark, Netherlands, RSA, Sweden
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-21
Company
Hasselager
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 97 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-0526-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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