The Recall Desk
ModerateFDA (Devices)·Z-0481-2016·Announced 2015-12-30

Siemens Artis Fluoroscopic X-ray Systems Recalled for Display Soldering Defect

Siemens is recalling 17 Artis fluoroscopic X-ray systems due to improper soldering in display modules that could cause video signal loss.

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, but the source explicitly states the issue has not been observed in the field and only sporadic cases were seen in factory screening, fitting the criteria for a voluntary precautionary recall with no reported harm.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 17 Artis interventional fluoroscopic X-ray systems with large displays. The recall is due to improper soldering in a limited number of large display bypass module components from a specific production lot.

This defect could potentially cause a loss of video signal. The source text notes that this issue has not been observed in the field and only sporadic cases have been observed in factory screening.

The affected units were distributed to hospitals and facilities in Illinois, Wisconsin, Massachusetts, Florida, Alabama, Tennessee, North Dakota, Ohio, Texas, California, New Jersey, and Michigan. Affected model numbers include 10094135, 10094137, 10094141, 10848280, 10848281, 10848282, and 10848355. Affected serial numbers include 123026, 147909, 123031, 103030, 147912, 147910, 147921, 147919, 131005, 121096, 125004, 137551, 121088, 109104, 109105, 109107, and 121085.

The recalled product

Product
Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.
Affected units
17

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 (20)

  • Model numbers 10094135
  • 10094137
  • 10094141
  • 10848280
  • 10848281
  • 10848282
  • 10848355. Serial Numbers 123026
  • 147909
  • 123031
  • 103030
  • 147912
  • 147910
  • 147921
  • 147919
  • 131005
  • 121096
  • 125004
  • 137551
  • 121088
  • 109104

Distribution

Distributed in 12 states:

Same manufacturer · Siemens Medical Solutions USA, Inc

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