The Recall Desk
HighFDA (Devices)·Z-1795-2013·Announced 2013-07-31

Siemens Axiom Aristos MX Flat Panel Imager Recalled for Finger Injury Risk

Siemens is recalling 401 Axiom Aristos MX digital imagers because the table top float function can trap and crush fingers.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (crush injury) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 401 units of the Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. These devices are used for diagnostic X-ray imaging and were distributed nationwide. The recall covers units with serial numbers 1052 through 2500.

The recall was issued due to a potential hazard to patients or operators when using the "table top float" function. When repositioning a patient lying on the table top and releasing it, fingers can become trapped between the table top and the detector tray. If the table top moves while fingers are trapped, they can be squeezed.

Healthcare facilities should contact Siemens to arrange for a repair or replacement. Users should stop using the "table top float" function until the issue is resolved to prevent potential finger injuries.

The recalled product

Product
Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for diagnostic X-ray imaging.
Affected units
401

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 (1)

  • Model Number 5895003 with serial numbers 1052 through 2500.

Distribution

Distributed nationwide across the United States.

Same manufacturer · Siemens Medical Solutions USA, Inc

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