550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiation f...

FDA Device Recall #Z-1645-2014 — Class II — April 1, 2014

Recall Summary

Recall Number Z-1645-2014
Classification Class II — Moderate risk
Date Initiated April 1, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Medical Solutions USA, Inc
Location Malvern, PA
Product Type Devices
Quantity 120

Product Description

550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiation for therapeutic treatment of cancer.

Reason for Recall

Table may lose calibration during patient treatment, which may cause the possibility of mistreatment.

Distribution Pattern

USA ( nationwide) Distribution.

Lot / Code Information

material #8139789 , 5857912, 7360717, 1940035, 8139789, 4504200, 5863472, serial # 5377, 5087, 70-4262, 5170, 5282 5506 3287 5527 5517 70-4378 3695 5364 5060 5205 5688 5743 70-4283 5190 5157 5343 5844 5148 5391 5300 70-4296 5474 70-4363 70-4368 3793 3817 5833 5899 5207 5355 70-4159 3524 5281 5894 5374 5558 3631 3835 5784 2765 5367 70-4354 70-4356 5540 5488 5590 5657 5350 5821 3413 5222 5843 5179 70-4129 5851 5098 5153 5700 5410 3825 5865 5118 5548 3769 5861 70-4188 5748 70-4317 5737 5830 5385 5656 3778 5088 5665 5823 5353 5630 5480 5096 5572 3873 5417 4059 5500 5388 70-4379 5226 5601 5640 5033 5177 5707 5398 4091 5532 70-4306 70-4161 5424 5755 5326 5145 5699 4079 4082 70-4077 70-4113 5525 5419 3975 5093 5481 5396 3089 5095 5154

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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.