The Recall Desk
ModerateFDA (Devices)·Z-1594-2016·Announced 2016-05-11

Carestream Image Suite V4 Recalled for Incorrect Image Annotation Display

Carestream Health is recalling Image Suite V4 systems because a complaint reported that image annotations displayed 'L (Left)' instead of 'R (Right)'.

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, and the hazard involves a labeling/annotation error that could lead to misinterpretation of medical images, fitting the criteria for moderate severity without reported injuries.

Plain-English summary

Carestream Health Inc. is recalling CARESTREAM Image Suite V4 systems, including specific DICOM STORE SCP and standalone PACS bundles, due to a reported defect in image annotation display. The recall involves 37 units in the United States and 269 units distributed to foreign countries.

The recall was initiated after Carestream Health received a complaint from a foreign hospital stating that the annotation on the image overlay was displayed as "L (Left)" when it should have been "R (Right)". This error could lead to the misinterpretation of medical images during review.

The affected equipment includes various configurations of the Image Suite V4 and Carestream PRO systems. Users of these systems should contact Carestream Health for further instructions on how to resolve the annotation display issue.

The recalled product

Product
CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 6566988; Image Suite V4 Bundles: IMAGESUITE STANDALONE PACS: REF/Catalog # 1741289, IMAGESUITE STANDALONE PACS FOR INDIA: REF/Catalog # 1741297;
Manufacturer
Carestream Health Inc
Category
Medical Device — Image Management System
Hazard

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)

  • Equipment ID Numbers for US units: 54842754
  • 54841669
  • 54842420
  • 85013694
  • 54842411
  • 54840875
  • 54841972
  • 54841973
  • 85017625
  • 58000559
  • 85013233
  • 6482124
  • 54841111
  • 54842348
  • 54842197
  • 54842276
  • 52412604
  • 47441885
  • 85013624
  • 85013511

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Carestream Health Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

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Same hazard · mis labeling

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