Recall Z-0782-2020— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2019-11-25, terminated 2020-05-06. It names one FDA 510(k) clearance: K132094. Product: Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical application. Reason: During a routine inspection of a system, a crack on the C-arm holder was discovered. In the event the C-arm holder has a crack, the stability of the C-arm may be compromised and could lead to deformations of the C-arm. In very unlikely cases, an extreme impact to the C-arm such as heavy collision with a wall or table, may lead to a detachment of the C-arm and could potentially result in injury to patients and staff..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-11-25
- Terminated
- 2020-05-06
- 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
Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical application
Reason for recall
During a routine inspection of a system, a crack on the C-arm holder was discovered. In the event the C-arm holder has a crack, the stability of the C-arm may be compromised and could lead to deformations of the C-arm. In very unlikely cases, an extreme impact to the C-arm such as heavy collision with a wall or table, may lead to a detachment of the C-arm and could potentially result in injury to patients and staff.
Data sourced from openFDA. This site is unofficial and independent of the FDA.