Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-2341-2012 · Posted 2012-09-10

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2012-04-30
Date Terminated2012-09-20
Product Quantity5

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.

Firm Action

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

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010942U04Siemens Medical Solutions USA, Inc. · 2001-04-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑