FDAFDA · Food and drugs·Recall number Z-1036-2013
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE AG TH, Part No. 5863506, Current R630; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Published April 10, 2013 · Recall initiated: March 5, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- Worldwide Distribution
- Lot
- All units of these models.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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