Recall Z-0558-2019 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
| Date | Oct 26, 2018 |
| Status | Terminated |
| Reason | This recall has been initiated due to a possible leakage of a hose in the cooling unit of the X-ray tube. The Artis zee system may lose coolant due to a possible leakage in a hose of the cooling unit in the X-ray tube. This will cause the X-ray tube not to be sufficiently cooled down. As a result, the system will display a message Tube hot, have a break . The X-ray will be blocked several minutes later and to prevent any damage to the machine the following message will be displayed NO XRAY, TUBE TOO HOT . This issue is very sporadic and may occur during an ongoing clinical procedure. Use of |
| Root cause | Process control |
| Action | On October 26, 2018, the firm, Siemens Healthineers, distributed "URGENT: MEDICAL DEVICE CORRECTION" letters to affected customers. The letters informed customers of the product, problem and actions to be taken. The customers were instructed to do the following: promptly notify and instruct accordingly all the staff at your organization who need to be aware of this notice and Immediately examine your inventory and quarantine product subject to recall (if applicable). In addition, if you may have further distributed this product, please identify your customers and notify them at once of this p |
| Quantity | 64 (16 in US) |
| Distribution | US Distribution to states of: AR, CA, KS, KY, MD, MN, NM, OK, PA, RI, TX, and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073290 | ARTIS ZEE AND ZEEGO Siemens Medical Solutions USA, Inc., Feb 11, 2008 |