The Recall Desk
ModerateFDA (Devices)·Z-1505-2014·Announced 2014-04-30

Siemens Multix Fusion Radiographic System Recall for Loose Hose Holder

Siemens is recalling 12 Multix Fusion radiographic systems because a corrugated hose holder may become loose. The issue requires verification and securing of the holder.

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: This is a Class II recall involving a mechanical component that may become loose, but no injuries or illnesses are reported, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 12 units of the Multix Fusion radiographic system. This system is used in hospitals, clinics, and medical practices for whole-body radiographic exposures. The recall involves model numbers 10746665, 10746666, 10847610, and 10746700.

The recall was initiated because the corrugated hose holder located above the 3D rail on the system was observed to become loose. According to the installation instructions, this holder should be affixed with a transversal carriage, Loctite 243, and a torque of 10nm during installation. Siemens has initiated an update instruction to verify and secure the hose holder with Loctite 243.

The affected units were distributed in the states of Alaska, Pennsylvania, Kentucky, Ohio, Wisconsin, Michigan, Florida, and New York. Healthcare facilities using these systems should contact Siemens to verify the status of the hose holder and ensure it is properly secured.

The recalled product

Product
MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatri
Affected units
12

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 (4)

  • model nos. 10746665
  • 10746666
  • 10847610
  • 10746700

Distribution

Distributed in 8 states:

Same manufacturer · Siemens Medical Solutions USA, Inc

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