Recall Z-1288-2021— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2021-02-26, terminated 2021-08-11. It names one FDA 510(k) clearance: K193326. Product: Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.. Reason: Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power supply problem..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-02-26
- Terminated
- 2021-08-11
- Firm location
- Malvern, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Reason for recall
Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power supply problem.
Data sourced from openFDA. This site is unofficial and independent of the FDA.