Siemens Linear Accelerators Recalled for Potential Patient Collision Risk
Siemens Medical Solutions is recalling 160 linear accelerators because automatic treatment movements could cause the machine to collide with patients.
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 injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 160 Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS equipped with the Automatic Sequenced Cancer Treatment Delivery Option. The recall covers units with specific material numbers and serial numbers below 3094.
The recall was issued because a safety risk exists with the SIMTEC Auto Field Option. During automatically sequenced treatment, the automatic movements of the gantry and the tabletop have the potential to lead to a collision with the patient.
The affected devices were distributed nationwide and in regions outside the United States, including Canada and Mexico. Consumers and healthcare providers should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the recall and potential corrective actions.
The recalled product
- Product
- Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 160
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 (14)
- material numbers: 01940035
- 04504200
- 05672977
- 05693908
- 05857912
- 05857920
- 08139789
- 08319758
- 08490005
- 08515520
- 09401654
- 09401746
- 09822693
- with serial numbers below 3094.
Distribution
Distributed nationwide across the United States.
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