Recall Z-1501-2020— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2020-02-10, terminated 2020-08-31. It names one FDA 510(k) clearance: K081722. Product: Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.. Reason: The Ysio system may process incorrect internal values for the position of its ceiling tube stand. If in this situation the user activates longitudinal or transversal stand movement (by using the buttons at the tube head or the remote console), the systems controls may (depending on the values being processed) initiate a correction of the tube stand position, resulting in an unexpected movement..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-02-10
- Terminated
- 2020-08-31
- 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
Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.
Reason for recall
The Ysio system may process incorrect internal values for the position of its ceiling tube stand. If in this situation the user activates longitudinal or transversal stand movement (by using the buttons at the tube head or the remote console), the systems controls may (depending on the values being processed) initiate a correction of the tube stand position, resulting in an unexpected movement.
Data sourced from openFDA. This site is unofficial and independent of the FDA.