Recall Z-2341-2012— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2012-04-30, terminated 2012-09-20. It names one FDA 510(k) clearance: K010942. Product: Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system. Reason: Siemens has discovered a possible hazard to patients or hospital personnel when tilting the Uroskop Access system starting with serial number 6076. When tilting the table on the Uroskop Access table, the motor may become disconnected and the entire table assembly may fall on the floor..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-04-30
- Terminated
- 2012-09-20
- 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
Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system
Reason for recall
Siemens has discovered a possible hazard to patients or hospital personnel when tilting the Uroskop Access system starting with serial number 6076. When tilting the table on the Uroskop Access table, the motor may become disconnected and the entire table assembly may fall on the floor.
Data sourced from openFDA. This site is unofficial and independent of the FDA.