Reported Sep 4, 2013 · Terminated
PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 and Tabletop 550TxT, TT-S s/n…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 757 Arnold Dr Ste A · Martinez, CA · 94553-3615
Is this the product you have?
- PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 and Tabletop 550TxT, TT-S s/n 1001-1083
- Product UsageThe intended use of the SIEMENS branded, ARTISTE , ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer
- Lot codes and dates
- ONCOR, PRIMUS and ARTISTE
- Lican systems with tabletop component
Tabletop550TxTTT-A 08632296* Tabletop550TxTTT-S 10046140
- Amount recalled
- 179 active devices.
Where it was sold
Why it was recalled
Siemens has become aware of a customer complaint concerning the rail threaded holes of the 550TxT treatment tabletop. Due to a manufacturing error, the screws holding the side rails in position on the tabletop might break off.
This product could cause temporary or reversible health problems — stop using it.
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