FDA Device recall Z-1593-2016
CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490
- FDA Device
- Class II
- terminated
- Published 2016-05-11
On 2016-05-11 the FDA classified a Class II recall of CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490 by Carestream Health, citing carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as "L (Left)", when it s….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1593-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-15 |
| Published | 2016-05-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Carestream Health |
| Distribution | US |
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 Health, Inc. 150 Verona Street, Rochester, NY 14608 --- CLASSIFICATION NAME: System, Image Processing, Radiological The Carestream Image Suite System is an image management system whose intended use is to receive, process, review, display, print and archive images and data from CR and DR modalities. This excludes mammography applications in the United States.
Reason
Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as "L (Left)", when it should be "R(Right)".
Identifiers
| code_info | Equipment ID Numbers: US units: 8501-2596, 85018860, 8501-0954, 5241-2596, 5241-2546, 5241-2713, 5296-3447, 52414419,…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, 52962897, 4745-3986, 5241-2337, 85012262, 8501-5898, 8501-2602, 54838630, 52412670, 5296-3450, 5296-3449, 54838554, 52408157, 54838618, 5241-4547, 54842652, 52420675, 8501-2861, 52414685, 52414751, 5484-3086, 54838598, 52412367, 52414417, 54839211, 54838616, 4745-5991, 52412243, 54842667, 52417149, 52412340; -- Equipment ID Numbers for Foreign Units: Please contact CDRH Recall Group for list of affected Equipment ID Numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1593-2016%22
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