SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat beam opt...

FDA Device Recall #Z-0438-2014 — Class II — October 23, 2013

Recall Summary

Recall Number Z-0438-2014
Classification Class II — Moderate risk
Date Initiated October 23, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Medical Solutions USA, Inc
Location Martinez, CA
Product Type Devices
Quantity 26 units

Product Description

SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat beam option (Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, GERMANY and distributed SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Martinez, CA

Reason for Recall

A safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Accelerator (LINAC) in combination with IMRT or mARC (rotational IMRT) treatments using unflat (flattening filter free) beams. In case there are many long periods of field shape changes in a treatment plan, the dose due to dark current radiation may sum up to a significant value.

Distribution Pattern

Worldwide Distribution: USA (nationwide) including states of: FL, NC, NY, PA, TN, UT, and WI; and countries of: Angola, Brazil, Canada, P.R. China, Germany, India, Japan, Republic Korea, Poland, and Thailand.

Lot / Code Information

Serial Numbers: 5364, 5419, 5640, 5737, 5823, 5830, 5166, 5342, 5416, 5444, 5479, 5485, 5628, 5745, 5746, 5762, 5763, 5764, 5772, 5781, 5783, 5797, 5815, 5819, 5820, 5822, 5829, 5837, 5839, 5888, 5896, 5911, 5937

Other Recalls from Siemens Medical Solutions USA, Inc

Recall # Classification Product Date
Z-0786-2014 Class II SIMVIEW NT and SIMVIEW NT with IDI: October ... Dec 11, 2013
Z-0787-2014 Class II PRIMUS, ONCOR, ARTISTE Linac systems with compo... Dec 5, 2013
Z-0437-2014 Class II SIEMENS brand ONCOR series Linear Accelerator L... Oct 23, 2013
Z-2095-2013 Class II PRIMUS, ONCOR, ARTISTE Linac systems with compo... Jul 18, 2013
Z-1663-2013 Class II Siemens MEVATRON series, PRIMART (limited relea... May 29, 2013

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.