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Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797...

FDA Device Recall #Z-0711-2018 — Class II — September 28, 2017

Recall Summary

Recall Number Z-0711-2018
Classification Class II — Moderate risk
Date Initiated September 28, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Medical Solutions USA, Inc
Location Malvern, PA
Product Type Devices
Quantity 142

Product Description

Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.

Reason for Recall

The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. If the foot switch fails, it will no longer be able to be used to release radiation. The hand switch provided can be used to release exposures; however, fluoroscopic examinations will not be possible.

Distribution Pattern

Distributed in XX states: Ak, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, the District of Columbia, Guam, and Puerto Rico.

Lot / Code Information

Serial Numbers: 10006 10010 10017 10025 10044 10050 10051 10055 1044 1078 1081 15000 15001 15018 15021 15032 15044 15047 15056 15058 15060 15076 15088 15091 15105 15114 15116 15131 15144 15148 15149 17002 17004 17007 17011 17032 17050 17061 17062 17074 17078 17084 17142 20001 20002 20005 20009 20015 20024 20030 21004 21006 21017 21022 21028 21033 21039 21047 21052 21054 21075 21087 21089 21095 21096 21112 21114 21117 21132 21135 21150 21151 21173 21175 21178 21187 21188 21200 21201 21205 21208 21216 21225 21273 21274 21278 21281 21283 21294 21308 21309 21317 21327 21331 21337 21345 21347 21351 21352 21353 21363 21370 21377 21379 21384 21393 21400 21407 21414 21415 21421 21423 21425 21430 21440 21442 21444 21447 21448 21449 21450 21461 21462 21467 21473 21475 21484 21488 21494 21498 21500 21508 21509 21515 21519 21520 21523 21524 21536 21543 21550 21551

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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.

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