FDA Device

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

Hazard

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

What You Should Do

Remedy

Siemens sent an Medical Device Correction, Field Safety Notice of Improvement to End users in March 2014, informing them that a Siemens representative would install a software update. By installation of this software update the issues were solved by the following actions: 1. A plausibility check was introduced for comparing the two independent encoder systems of each table axis. 2. The time between two encoder comparisons was reduced to 50ms and an error code was introduced. Please include this Field Safety Notice in your Digital Linear Accelerator System Owner Manual chapter "Safety Advisory Letters" where it should remain. The relevant National Competent Authority has been informed of this update. We regret any inconvenience that this may cause, and we thank you in advance for your understanding. Further questions please call (610) 219-6300.

Affected by this recall?

Get a free legal consultation about this recall.

Talk to a Lawyer →

Affiliate link

Products

550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiation for therapeutic treatment of cancer.
Brand
Siemens Medical Solutions USA, Inc
UPC
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

Units Affected

120

Related Recalls

FDA DEVICE

Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa" Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical

 FDA DEVICE

AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts.

 FDA DEVICE

Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert.

 FDA DEVICE

Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.

 FDA DEVICE

PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar, Fully upholstered, OPTIONAL Heat or Heat & Massage, OPTIONAL LiquiCell. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors.