The Recall Desk
ModerateFDA (Devices)·Z-3211-2017·Announced 2017-10-04

Deerfield Imaging Recalls Starburst Adaptor Thumb Screws Due to Incorrect Thread

Deerfield Imaging is recalling six Starburst adaptor thumb screws because they have incorrect threads. The affected units were distributed in Illinois, Oregon, and Pennsylvania.

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 text does not report any injuries, illnesses, or hospitalizations. The hazard is a functional defect (incorrect thread) without reported harm, fitting the criteria for a moderate severity score.

Plain-English summary

Deerfield Imaging is recalling six Starburst adaptor thumb screws (Reference 113803) for IMRIS Deerfield Imaging systems. The recall is being conducted because the screws have incorrect threads.

The affected units are identified by the following serial numbers: 10006657, 10006658, 10006725, 10006660, 10006726, and 10006659. These products were distributed in Illinois, Oregon, and Pennsylvania.

Consumers and healthcare providers should stop using the affected thumb screws and contact Deerfield Imaging for further instructions or a replacement.

The recalled product

Product
IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw
Manufacturer
Deerfield Imaging
Affected units
6

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 (6)

  • Serial Numbers: 10006657
  • 10006658
  • 10006725
  • 10006660
  • 10006726
  • 10006659

Distribution

Distributed in 3 states:

Same manufacturer · Deerfield Imaging

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