Z-3190-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 26, 2018
- Initiation Date
- July 29, 2018
- Termination Date
- May 17, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 429 total
Product Description
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
Reason for Recall
Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g. at night).
Distribution Pattern
US nationwide distribution.
Code Information
164013 164011