Recall Z-0563-2014— Ziehm Imaging Inc
Class II · Terminated
Class II FDA medical device recall by Ziehm Imaging Inc, initiated 2013-11-21, terminated 2014-06-23. It names one FDA 510(k) clearance: K092438. Product: Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging. Reason: Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices..
- Recalling firm
- Ziehm Imaging Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-21
- Terminated
- 2014-06-23
- Firm location
- Orlando, FL, 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
Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Reason for recall
Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.
Data sourced from openFDA. This site is unofficial and independent of the FDA.