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Recall Observatory FDA recall evidence

Device product

Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system

Z-2341-2012

April 30, 2012

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 62988
Status
Terminated
Classification
Class II
Quantity
5
Official record key
device-enforcement:Z-2341-2012

Official wording

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.

Code information: Model number 5756130 -- serial numbers 6076, 6078, 6080, 6081, and 6082.

Distribution pattern: Nationwide distribution: USA including states of: IN, MI, MS, TN and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.