Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray recall
Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Why was Ziehm Vision(2) 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?
9760 9937 90067 90816 9763 9945 90102 90817 9828 9946 90103 90819 9840 9983 90142 90823 9841 9985 90636 90838 9848 9986 90699 90842 9849 90024 90715 90863 9855 90031 90750 90864 9856 90032 90758 90865 9894 90033 90773 90899 9896 90034 90774 90909 9923 90054 90813 90919 9924 90065 90814 9936 90066 90815
- Product
- Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
- Recalling firm
- Ziehm Imaging Inc
- Quantity
- 54 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)