ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation On...
FDA Device Recall #Z-0187-2013 — Class II — September 24, 2012
Recall Summary
| Recall Number | Z-0187-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 24, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Varian Medical Systems, Inc. Oncology Systems |
| Location | Palo Alto, CA |
| Product Type | Devices |
| Quantity | 205 |
Product Description
ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application.
Reason for Recall
An anomaly has been identified with the ARIA Oncology Information System Version 11 where Monitor Units of one fraction may be incorrect, when partial treatment is being continued.
Distribution Pattern
Worldwide Distribution - Nationwide(USA) and including the countries of Australia, Denmark and the United Kingdom.
Lot / Code Information
Model number: HIT Serial numbers: HIT0027 HIT1430R3 HIT2208R3 HIT3513 HIT2546 HIT2546 HIT2546 HIT0028 HIT1470M HIT2208R4 HIT3679 HIT2591 HIT2591 HIT2591 HIT0032 HIT1470R1 HIT2208R5 HIT3910 HIT2615 HIT2615 HIT2615 HIT0134 HIT1470R2 HIT2212 HIT3927M HIT2643 HIT2643 HIT2643 HIT0155 HIT1523M HIT2237M HIT3927R1 HIT2645 HIT2645 HIT2645 HIT0170M H1T1523R1 HIT2237R1 HIT3927R2 HIT2834 HIT2834 HIT2834 HIT0170R1 HIT1587M HIT2267M HIT3967 HIT2865 HIT2865 HIT2865 HIT0170R2 HIT1587R1 HIT2267R1 HIT4014 HIT2894M HIT2894M HIT2894M HIT0170R3 HIT1587R2 HIT2275M HIT4116 HIT2894R1 HIT2894R1 HIT2894R1 HIT0182 HIT1587R3 HIT2275R1 HIT4118M HIT2894R2 HIT2894R2 HIT2894R2 HIT0183 HIT1587R4 HIT2275R2 HIT4118R1 HIT2894R3 HIT2894R3 HIT2894R3 HIT0191M HIT1589M HIT2275R3 HIT4381 HIT2943 HIT2943 HIT2943 HIT0191R1 HITI589R2 HIT2275R4 HIT4555 HIT2953 HIT2953 HIT2953 HIT0191R2 HITI589R3 HIT2291M HIT4592 HIT2997 HIT2997 HIT2997 HIT0227 HIT1589R4 HIT2291R1 HIT4627 HIT3088M HIT3088M HIT3088M HIT0339M HIT1589R5 HIT2291R2 HIT4861 HIT3088R1 HIT3088R1 HIT3088R1 H1T0339R1 HIT1589R6 HIT2291R3 HIT4884 HIT3088R2 HIT3088R2 HIT3088R2 HIT0342 HIT1589R7 HIT2291R4 HIT4888M HIT3088R3 HIT3088R3 HIT3088R3 HIT0397 HIT1589R8 HIT2291R5 HIT4888R1 HIT3088R4 HIT3088R4 HIT3088R4 HIT0432M HIT1589R9 HIT2291R6 HIT4888R2 HIT3088R5 HIT3088R5 HIT3088R5 HIT0432R1 HIT1660M HIT2293 HIT4888R3 HIT3088R6 HIT3088R6 HIT3088R6 HIT0432R2 HIT1660R2 HIT2346M HIT4894 HIT3097 HIT3097 HIT3097 HIT0468M HIT1660R3 HIT2346R1 HIT4896 HIT3165 HIT3165 HIT3165 HIT0468R1 HIT1671 H1T2425 HIT4903 HIT3206 HIT3206 HIT3206 HIT0535 HIT1693 HIT2441 HIT4906 HIT3267 HIT3267 HIT3267 HIT0551 HIT1726 HIT2477M HIT4932M HIT1800 HIT2522 HIT0632M HIT1753 HIT2477R1 HIT4932R1 HIT0632R1 HIT1757 HIT2477R2 HIT4947 HIT0632R2 HIT1767M HIT2477R3 HIT4974 HIT0668 HIT1767R1 HIT2512M HIT4982 HIT0691M HIT1780 HIT2512R1 HIT5061 HIT0691R1 HIT2208R2 HIT3268 HIT0691R2.
Other Recalls from Varian Medical Systems, Inc. Oncology...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1163-2013 | Class II | Varian brand RPM Respiratory Gating System, RPM... | Mar 26, 2013 |
| Z-0867-2013 | Class II | Varian Eclipse Treatment Planning System for Ra... | Jan 28, 2013 |
| Z-0531-2013 | Class II | Varian brand ARIA Radiation Oncology, ARIA Onco... | Nov 5, 2012 |
| Z-2462-2012 | Class II | Varian brand Eclipse Treatment Planning System,... | Aug 17, 2012 |
| Z-2383-2012 | Class II | Varian brand Clinac, Trilogy, Novalis Tx, Uniqu... | Aug 14, 2012 |
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.