Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 11, 2016
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; Carestream PRO (Image Suite V4): PRO Medical Wireless GOS System-Desktop: REF/Catalog # 1741891, PRO Wireless System Laptop: REF/Catalog # 1741925, PRO Wireless System - w/o Computer: REF/Catalog # 1741933, PRO Tethered
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Carestream Health Inc recalled CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICO… - a moderate-severity action.
CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICO… was recalled by Carestream Health Inc in May 11, 2016. Reason: Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating th…. Check the official notice for the remedy. Verify recall #Z-1594-2016 with the FDA Devices before acting.
The recall
Carestream Health Inc issued this moderate-severity FDA Devices recall-Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating th….
- Moderate
- severity level
- Class II
- classification
- May 11, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1594-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1594-2016) was formally reported on May 11, 2016, with the manufacturer initiating the action on April 15, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Carestream Health Inc is listed as the recalling firm, operating out of Rochester, NY. Federal records list the affected scope as US: 37 units, Foreign: 269 units.
The documented reason for this recall is: 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)". Distribution data in the federal record shows the product reached: NY and OH for further distribution nationwide; Foreign distribution to the following countries: Afghanistan, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia & Herzgovena, Brazil, Bulgaria, Ca…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
US: 37 units, Foreign: 269 units
Related Recalls
6
3 from same agency
Product description
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; Carestream PRO (Image Suite V4): PRO Medical Wireless GOS System-Desktop: REF/Catalog # 1741891, PRO Wireless System Laptop: REF/Catalog # 1741925, PRO Wireless System - w/o Computer: REF/Catalog # 1741933, PRO Tethered System Desktop: REF/Catalog # 1741941, PRO Tethered System Laptop: REF/Catalog # 1741958, PRO Tether System - w/o Computer: REF/Catalog # 1741966, PRO Fixed System - w/o Computer: REF/Catalog # 1741974, PRO Medical Wireless CsI System-Desktop: REF/Catalog # 1741982, PRO Wireless System Laptop: REF/Catalog # 1742006, PRO Wireless System - w/o Computer: REF/Catalog # 1742014, PRO Tethered System Desktop: REF/Catalog # 1742022, PRO Tethered System Laptop: REF/Catalog # 1742055, PRO Tether System - w/o Computer: Catalog # 1742063; PRO Fixed System - w/o Computer: REF/Catalog # 1742089 -- Made in U.S.A. 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 for recall
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)".
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1594-2016 |
| Date reported | May 11, 2016 |
| Date initiated | April 15, 2016 |
| Recalling firm | Carestream Health Inc |
| Firm location | Rochester, NY |
| Affected scope | US: 37 units, Foreign: 269 units |
| Distribution | NY and OH for further distribution nationwide; Foreign distribution to the following countries: Afghanistan, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia & Herzgovena, Brazil, Bulgaria, Cambodia, Canada, Chad… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1594-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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; Carestream PRO (Image Suite V4): PRO Medical Wireless GOS System-Desktop: REF/Catalog # 1741891, PRO Wireless System Laptop: REF/Catalog # 1741925, PRO Wireless System - w/o Computer: REF/Catalog # 1741933, PRO Tethered System Desktop: REF/Catalog # 1741941, PRO Tethered System Laptop: REF/Catalog # 1741958, PRO Tether System - w/o Computer: REF/Catalog # 1741966, PRO Fixed System - w/o Computer: REF/Catalog # 1741974, PRO Medical Wireless CsI System-Desktop: REF/Catalog # 1741982, PRO Wireless System Laptop: REF/Catalog # 1742006, PRO Wireless System - w/o Computer: REF/Catalog # 1742014, PRO Tethered System Desktop: REF/Catalog # 1742022, PRO Tethered System Laptop: REF/Catalog # 1742055, PRO Tether System - w/o Computer: Catalog # 1742063; PRO Fixed System - w/o Computer: REF/Catalog # 1742089 -- Made in U.S.A. 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. Recalled by Carestream Health Inc. Units affected: US: 37 units, Foreign: 269 units.
Why was this product recalled? ▼
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)".
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 11, 2016. Severity: Moderate. Recall number: Z-1594-2016.
Where was the recalled product distributed? ▼
Distribution: NY and OH for further distribution nationwide; Foreign distribution to the following countries: Afghanistan, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia & Herzgovena, Brazil, Bulgaria, Cambodia, Canada, Chad, Chile, China, Colombia, Croatia, Czech Rep., Djibouti, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Italy, Jamaica, Japan, Jordan, Kuwait, Kyrgyzstan, Laos, Latvia, Lebanon, Liechtenstein, Lithuania, Macao, Malaysia, Mexico, Montenegro, Myanmar (Burma), Nepal, Netherlands, New Zealand, Niger, Norway, Oman, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Scotland, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Taiwan, thailand, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1594-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 11, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.