The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1593-2016·Announced 2016-05-11

Carestream Image Suite V3 Recalled for Incorrect Image Annotation

Carestream Health is recalling Image Suite V3 units due to a software error that displays incorrect left/right image annotations.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific hazard is a software labeling error (incorrect left/right annotation) which is a functional defect rather than a direct physical injury risk, fitting the Moderate severity criteria for minor labeling or functional errors without reported serious injury.

Plain-English summary

Carestream Health, Inc. is recalling Carestream Image Suite V3 units, including specific MINI-PACS configurations, due to a software defect. The recall was initiated after a complaint from a foreign hospital reported that the annotation on the image overlay was displayed as "L (Left)" when it should have been "R (Right)".

The affected product is an image management system intended to receive, process, review, display, print, and archive images and data from CR and DR modalities. The system is manufactured in the USA by Carestream Health, Inc. The recall covers 50 units in the United States and 2,499 units distributed to foreign countries.

In the United States, the units were distributed in New York and Ohio for further distribution nationwide. Foreign distribution includes numerous countries across multiple continents. Users should contact Carestream Health or the FDA for instructions on how to resolve the annotation error.

The recalled product

Product
CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F IMG ST/ POC&VITA /INDIA: REF/Catalog # 1036425 -- Made in USA by: Carestream…
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: US units: 8501-2596
  • 85018860
  • 8501-0954
  • 5241-2596
  • 5241-2546
  • 5241-2713
  • 5296-3447
  • 52414419
  • 52414455
  • 5241-2640
  • 5241-2716
  • 54838552
  • 5483-8502
  • 8501-4665
  • 52408158
  • 85014687
  • 54839128
  • 5483-9212
  • 52412539
  • 52414661

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

Same manufacturer · Carestream Health Inc

See all →

Same hazard · mis labeling

See all →

Similar recalls