Z-2302-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2020
- Initiation Date
- April 30, 2020
- Termination Date
- September 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 US
Product Description
Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q floor Model: 10848280; Artis Q ceiling Model: 10848281; Artis Q biplane Model:10848282; Artis zee ceiling Model: 10094137; Artis zee floor Model: 10094135 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Reason for Recall
Artis systems containing a Multi Display Manager of a specific lot, the power distributor may lead to an increased electrical contact resistance or the interruption of electrical contact, and result in planned procedures to be terminated and performed on an alternative x-ray system
Distribution Pattern
US Nationwide distribution.
Code Information
Serial Numbers: Serial 125253 103340 121526 121521 103335 109621 138311 148418 147237 109620 136555 121520 121525 121518 125254