The Recall Desk
SevereFDA (Devices)·Z-1645-2014·Announced 2014-05-28

Siemens 550 TxT Treatment Table Recalled for Calibration Loss

Siemens Medical Solutions is recalling 120 550 TxT Treatment Tables because they may lose calibration during treatment, posing a risk of patient mistreatment.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury reports or structural defects are rated as Severe (4). The potential for radiation mistreatment constitutes a significant risk of harm.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 120 units of the 550 TxT Treatment Table, a component of the Digital Linear Accelerator (LINAC) used to deliver X-ray radiation for cancer treatment. The recall was initiated because the table may lose calibration during patient treatment, which creates the possibility of mistreatment.

The affected products were distributed nationwide in the United States. The recall includes specific material numbers and serial numbers listed in the agency's official documentation.

Healthcare facilities and consumers should stop using the affected treatment tables and contact Siemens Medical Solutions USA, Inc. for further instructions on how to resolve the issue.

The recalled product

Product
550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiation for therapeutic treatment of cancer.
Affected units
120

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • material #8139789
  • 5857912
  • 7360717
  • 1940035
  • 8139789
  • 4504200
  • 5863472
  • serial # 5377
  • 5087
  • 70-4262
  • 5170

Distribution

Distributed nationwide across the United States.

Same manufacturer · Siemens Medical Solutions USA, Inc

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