Z-0298-2021 Class II Terminated
FDA device recall Z-0298-2021 was initiated by Siemens Medical Solutions USA, Inc on September 21, 2020 and is designated Class II. Reason for recall: Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution). The recall status is terminated (terminated August 3, 2021). Affected quantity: 22 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 4, 2020
- Initiation Date
- September 21, 2020
- Termination Date
- August 3, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22 units
Product Description
Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. The Artis one can also support the acquisition of position triggered imaging for spatial data synthesis.
Reason for Recall
Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution).
Distribution Pattern
US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, IN, LA, MI, MO, NC, NJ, NY, PA, TX, WA.
Code Information
Serial Numbers: 82010 82038 82039 82040 82044 82054 82065 82066 82070 82102 82105 82108 82109 82205 82213 82217 82267 82308 82354 82355 82378 82383