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 brand 550 TxT Patient Table, Part No. 7346534, Distributed by and/or Manufactured by Siemens AG, Medical Solutions, Germany

FDA Recall Z-0166-2011 · Posted 2010-10-28

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAI
Date Initiated2010-03-31
Date Terminated2012-03-01
Product Quantity326 units

Reason for Recall

An increase in voltage may cause a short circuit of a power transistor that may cause a smoldering and smoking effect of the electrical wiring and also an unexpected lowering of the Table. Both issues present the potential for injury to a patient or the operator.

Firm Action

Siemens sent a Customer Information Letter on March 31, 2010, to all consignees. The letter identified the product, the problem, and the action that should be taken. Siemens implemented minor modifications to address the issues. No further action was required for the continual operation of the 550TxT Table. For questions regarding this recall call 925-602-8083.

Root Cause

Other

Distribution Pattern

Worldwide Distribution including USA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050422550 TXT TREATMENT TABLESiemens Medical Solutions USA, Inc. · 2005-03-18

Official Source

View FDA Recall →

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

↑