Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray recall
Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Why was Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
50104 50694 50704 50714 50812 50875 50105 50695 50705 50785 50813 50901 50106 50696 50706 50786 50815 50902 50107 50697 50707 50802 50817 50925 50108 50698 50708 50803 50818 50926 50109 50699 50709 50804 50819 50927 50653 50700 50710 50805 50820 50937 50663 50701 50711 50808 50872 50939 50671 50702 50712 50810 50873 50693 50703 50713 50811 50874
- Product
- Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
- Recalling firm
- Ziehm Imaging Inc
- Quantity
- 58 devices
- Distribution
- USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Hawaii.
- Recall date
- January 1, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)