The Recall Desk
SevereFDA (Devices)·Z-0168-2016·Announced 2015-11-04

Siemens Medical Solutions Recalls 158 Radiation Therapy Machines

Siemens Medical Solutions is recalling 158 radiation therapy machines due to a potential safety risk of the gantry colliding with patients or treatment tables.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural/mechanical defect in a medical device that poses a risk of physical injury (collision) to patients, which aligns with the 'Severe' criteria for significant injury reports or structural defects in high-risk devices.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 158 units of radiation therapy machines, including the ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, and ARTISTE models. These devices are intended to deliver x-ray radiation for the therapeutic treatment of cancer.

The recall is issued because of a potential safety risk where the LINAC gantry could collide with the patient or the treatment table. This risk is associated with the use of automatically sequenced treatment delivery techniques utilizing the SIMTEC Auto Field Sequence Option.

The affected units were distributed nationwide. Siemens Medical Solutions USA, Inc. is the recalling firm. Consumers and healthcare providers should contact the manufacturer for further instructions regarding the recall and corrective actions.

The recalled product

Product
ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, ARTISTE; intended use is to deliver x-ray radiation for therapeutic treatment of cancer.
Affected units
158

Distribution

Distributed nationwide across the United States.

Same manufacturer · Siemens Medical Solutions USA, Inc

See all →