Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic recall
Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Why was Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic 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?
90842
- Product
- Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
- Recalling firm
- Ziehm Imaging Inc
- Quantity
- 1 device
- 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)