PlainRecalls
FDA Devices Moderate Class II Terminated

Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.

Reported: September 17, 2014 Initiated: July 7, 2014 #Z-2292-2014

Product Description

Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.

Reason for Recall

It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia systems with software version VB10C to VB10F and automatic exposure control, a highly unlikely malfunction can result in longer radiation exposure than required. This may also result in an overexposed image that is not of diagnostic quality. As a result the taken examination needs to be repeated. Thi

Details

Units Affected
192
Distribution
Nationwide Distribution.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled? ▼
Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 192.
Why was this product recalled? ▼
It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia systems with software version VB10C to VB10F and automatic exposure control, a highly unlikely malfunction can result in longer radiation exposure than required. This may also result in an overexposed image that is not of diagnostic quality. As a result the taken examination needs to be repeated. Thi
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 17, 2014. Severity: Moderate. Recall number: Z-2292-2014.

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