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AXIOM Artis dTA, Model Number 7008605

FDA Device Recall #Z-2019-2019 — Class II — June 12, 2019

Recall Summary

Recall Number Z-2019-2019
Classification Class II — Moderate risk
Date Initiated June 12, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Medical Solutions USA, Inc
Location Malvern, PA
Product Type Devices
Quantity 178

Product Description

AXIOM Artis dTA, Model Number 7008605

Reason for Recall

A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.

Distribution Pattern

US Nationwide Distribution

Lot / Code Information

Serial Numbers: 55163 55713 55304 55435 55567 55407 55412 55310 55470 55164 55187 55206 55091 55059 55204 55377 55307 55171 55368 55210 55133 55135 55477 55250 55318 55196 55230 55277 55423 55320 55387 55576 55438 55503 55046 55308 55139 55039 55270 55188 55314 55381 55550 55365 55574 55415 55109 55337 55322 55272 55157 55234 55548 55282 55575 55211 55410 55150 55079 55262 55259 55531 55388 55275 55276 55254 55569 55177 55269 55292 55041 55404 55425 55183 55441 55125 55369 55437 55136 55356 55191 55103 55400 55483 55083 55526 55088 55243 55056 55408 55715 55233 55416 55256 55074 55212 55153 55325 55312 55273 55213 55401 55170 55284 55469 55067 55048 55216 55241 55708 55202 55461 55154 55167 55342 55468 55219 55553 55217 55386 55396 55513 55279 55414 55347 55042 55294 55160 55286 55036 55362 55436 55375 55131 55062 55107 55411 55052 55096 55156 55289 55374 55705 55017 55223 55149 55141 55089 55305 55078 55227 55040 55200 55186 55184 55232 55358 55222 55313 55085 55090 55324 55045 55382 55350 55353 55405 55043 55439 55473 55070 55545 55434 55118 55455 55263 55274 55238

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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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