The Recall Desk
ModerateFDA (Devices)·Z-2333-2015·Announced 2015-08-12

Siemens Biograph mCT X-4R Systems Recalled for Missing Locking Ring

Siemens Medical Solutions is recalling two Biograph mCT X-4R systems because they may be missing a locking ring on optional ceiling mounts.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or fatalities, fitting the criteria for a moderate severity score.

Plain-English summary

Siemens Medical Solutions USA Inc. is recalling two units of the Biograph mCT X-4R, Model Number 10248670. The recall is due to a defect where the emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.

The affected units have serial numbers 1009 and 11061. These products were distributed in the state of Texas and in the countries of Germany, France, Russia, Denmark, and Switzerland.

Healthcare facilities should contact Siemens Medical Solutions USA Inc. for instructions on how to resolve the issue. Consumers should not use the affected equipment until the defect is corrected.

The recalled product

Product
Biograph mCT X-4R, Model Number 10248670
Affected units
2

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 (2)

  • SERIAL NUMBERS: 1009
  • 11061

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 8 recalled by Siemens Medical Solutions USA Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Same manufacturer · Siemens Medical Solutions USA Inc.

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