Recall Z-2312-2018— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2018-05-01, terminated 2019-05-16. It names one FDA 510(k) clearance: K141574. Product: Artis zee floor MN, Material no. 10094142, for angiography and whole body radiographic/fluoroscopic procedures.. Reason: After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, the system cannot be operated normally. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-01
- Terminated
- 2019-05-16
- Firm location
- Malvern, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Artis zee floor MN, Material no. 10094142, for angiography and whole body radiographic/fluoroscopic procedures.
Reason for recall
After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, the system cannot be operated normally. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
Data sourced from openFDA. This site is unofficial and independent of the FDA.