Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system
FDA device recall Z-2341-2012 · posted 2012-09-10 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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.
- Action taken
- Siemens sent a Update instructions letter dated April 2012, to all affected customers. The safety instruction letter identified the product the problem and the action needed to be taken by the customer. The update has been completed successfully. The customer has been informed of the benefits of improvements resulting from this update. Further questions please call (610) 219-4834.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 5
- Distribution
- Nationwide distribution: USA including states of: IN, MI, MS, TN and TX.
- Date initiated
- 2012-04-30
- Date posted
- 2012-09-10
- Date terminated
- 2012-09-20
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| U04 (K010942) | Siemens Medical Solutions USA, Inc. | 2001-04-12 |