AXIOM Artis zee/zeego recall
AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed…
Why was AXIOM Artis zee/zeego recalled?
Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can result in a cooling system failure and subsequent system failure. This leak can occur sporadically in affected systems.
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?
Serial Numbers: Artis Q Ceiling 109033, 109135, 109141, 109123, 109080, 109074, 109119, 109016, 109118, 109155, 109067, 109066, 109068, 109134, 109133, 109084, 109011, 109096, 109159, 109130, 109143, 109102, 109015, 109144, 109009, 109057, 109108, 109103, 109038, 109040, 109034, 109129, 109137, 109029, 109136, 109064, 109132, 109058, 109145, 109050, 109076, 109007, 109072, 109075, 109071, 109091, 109090, 109041, 109039, 109060, 109146, 109088, 109092, 109032, 109021, 109048, 109020, 109036, 109043, 109161, 109101, 109105, 109104, 109107, 109047, 109031, 109028, 109027, 109120, 109010, 109093, 109157, 109156, 109069, 109158, 109044
- Product
- AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 986 systems in total
- Distribution
- US Nationwide Distribution in the states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY including Puerto Rico.
- Recall date
- April 6, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)