Recall Z-0695-2020 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C
| Date | Nov 14, 2019 |
| Status | Terminated |
| Reason | In affected Artis zee floor Interventional Fluoroscopic X-Ray Systems, the activation of a collision sensor will cause a block the movement of the floating tabletop and could result in a delay or interruption of a procedure. |
| Root cause | Software design |
| Action | On November 14, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating: URGENT: MEDICAL DEVICE CORRECTION Dear Customer, This letter is to inform you of a corrective action that will be performed to prevent a possible hazard to patients, operators, or other persons and equipment due to a potential software error in software version VC21C and serial numbers 140422, 140423 or 140430. Artis zee systems with software version VC21C and serial # 140422, 140423 or 140430 This potential software issue has no influence on the previous treatment/diagnosis of patie |
| Quantity | 3 |
| Distribution | US: WA and TX International: Denmark |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181407 | Artis zee/zeego & Artis Q/Q.zen Siemens Medical Solution USA, Inc., Aug 15, 2018 |