Recall Z-2283-2018— Siemens Medical Solutions USA, Inc
Class II · Completed
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2018-05-01, terminated 2020-03-18. It names one FDA 510(k) clearance: K163286. Product: ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000. Reason: If the C-arm is manually moved in the longitudinal direction to a fully extended position, the system's safety stop mechanism may be activated. As a result, the C-arm stops the movement and can drop up to 20 mm (0.8 ). Under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the C-arm drop. This could lead to a situation in which it is necessary to stop the clinical treatment or continue the treatment on an alternative system..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Completed
- Initiated
- 2018-05-01
- Terminated
- 2020-03-18
- 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 Pheno Interventional Fluoroscopic X-Ray System, Model 10849000
Reason for recall
If the C-arm is manually moved in the longitudinal direction to a fully extended position, the system's safety stop mechanism may be activated. As a result, the C-arm stops the movement and can drop up to 20 mm (0.8 ). Under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the C-arm drop. This could lead to a situation in which it is necessary to stop the clinical treatment or continue the treatment on an alternative system.
Data sourced from openFDA. This site is unofficial and independent of the FDA.