Recall Z-2095-2013— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2013-07-18, terminated 2014-11-24. It names one FDA 510(k) clearance: K993425. Product: 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 Usage: The 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.. Reason: 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..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-18
- Terminated
- 2014-11-24
- Firm location
- Martinez, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 Usage: The 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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.