Siemens Recalls Linear Accelerator Tabletops Due to Screw Breakage Risk
Siemens is recalling specific linear accelerator tabletops because manufacturing errors may cause screws to break off, potentially affecting patient safety.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where a mechanical failure could lead to injury, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling specific PRIMUS, ONCOR, and ARTISTE linear accelerator systems equipped with 550TxT treatment tabletops. The recall involves 179 active devices distributed worldwide, including in the United States and numerous international locations.
The recall is due to a manufacturing error in the rail threaded holes of the 550TxT treatment tabletop. This error may cause the screws holding the side rails in position to break off. The affected components are identified by serial number ranges 1001-1233 for the TT-A model and 1001-1083 for the TT-S model.
These devices are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. Siemens has identified the issue through a customer complaint. Users of these devices should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the potential defect.
The recalled product
- 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…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 179
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- ONCOR
- PRIMUS and ARTISTE Lican systems with tabletop component: Tabletop
- 550TxT
- TT-A 08632296* Tabletop
- TT-S 10046140
Distribution
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